Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Resmed has received a small number of reports regarding the performance of the internal
battery, where the false activation of a fuse leads to shut down of the internal battery. prior to
loss of battery power due to this issue one or more of the following alarms were activated in all
reports received to date:
battery inoperable
power fault / no charging
device overheating .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
When an affected s3 or s2 fluid pack is inserted to the cobas b 221 instrument, it will display an error message “transponder error”. the instrument cannot start measurements until any affected fluid pack is replaced with an unaffected one.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Roche received complaints about falsely low crea plus results for patients with a toxic level of acetaminophen under treatment with n-acetylcysteine (nac). other complaints were obtained describing falsely low results of crea plus after intravenous injection of metamizole. the crea plus results were below the measuring range, while plausible results were obtained with the crea jaffé method. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
The ifus (instructions for use) for vancomycin on cobas c 311/501/502 and modular analytics p-module
state an incorrect method comparison against cobas integra® 800.
since the cobas integra reagent is not yet adapted, results generated with cobas integra are still up to 20 %
higher than with cobas c or modular analytics p-module. the method comparison shown may lead to the
assumption that both methods are comparable and may affect the interpretation of vancomycin test results.
the issue can potentially lead to misinterpretation of results. in case that the first result has been generated with
integra and the following result using cobas/hitachi assay, the difference between assays might be interpreted
as decrease in vancomycin concentration which can further trigger the increase in the dosage. in this case, a
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
If you are capturing images at 4x, 10x, and 40x magnifications while using a measuring tool, it is likely that the tumor parameters may be underestimated or overestimated, which may lead to patient misinterpretation.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
We regret to inform you that in very rare cases a software (sw) malfunction in the sample&control datafile can
occur which may lead to a potential data mismatch. this sw malfunction only occurs:
∑ when the “sample data clear” function is not performed daily as indicated in the operator’s manual, and
∑ when the sample&control datafile of the cobas e 411 analyzer is filled with > 2000 records.
all tests that are run on cobas e 411 are potentially affected whereas the impact of the data mismatch cannot be
predicted. roche has received a total of four customer complaints for this issue.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
We have informed you in the previous version of this document that a sample mismatch may occur (i.E orders are
shifted) in the immunochemistry modules (cobas e 602, cobas e 601 and e170 modules) due to a software
limitation. based on new information received we would like to give you an update.
the sample mismatch is caused by a software limitation and only occurs if the following conditions are
simultaneously met (i.E. very rare occurrence):
immunochemistry module (cobas e 602, cobas e 601 and e170 modules) is included in its respective
system (cobas 8000 modular analyzer series, cobas 6000 analyzer series, modular analytics,
modular analytics evo). .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Internal investigations have shown that interference with the active substances sulfasalazine and sulfapyridine may occur in tests using nad (h) or nadp (h) (annex 1) in their reaction. consequence
may be the false lower / higher results of said tests as indicated in table 1. the interference is most likely the absorption of sulfasalazine and sulfapyridine at a wavelength of 340 nm equal to the wavelength at which the absorption of the nad (h) or nadp assays is measured. (h).
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Some accu-chek inform ii base units (bu) and handheld base units (hbu), used for coaguchek professional
meters and cobas h232 meters, might produce transmission errors between the meter and the data management
system (dms; e.G. cobas it 1000 or any other 3rd party software). the transmission errors present in the form of
data loss. this could happen, in rare cases, when the bu/hbu is connected via a usb to a pc.
if your bu/hbu is connected via ethernet or if you use wi-fi, you will not experience this issue.
if your bu/hbu is connected to a pc via usb, the data loss may cause invalid data exchange. for example, in the
case of the accu-chek inform ii meter, this is indicated by numerous messages sent from the meter to the dms in
the form of “unexpected sw failure 11800” events.
please note that the error message “unexpected sw failure 11800” is quite unspecific. it might have other causes
and is therefore no clear indicator for the data loss. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
We have become aware of a software issue that may lead to erroneous results on cobas c 111 analyzer (without
ise unit) in very rare cases. cobas c 111 analyzer with ise unit are not affected as long as the ise is in status
‘ready’. to date, no field issue has been reported where the identified software error actually produced wrong
results.
under very rare constellations of already used and unused cuvettes remaining on the cobas c 111 analyzer rotor a
measurement timing error “7002: 108000572 a software error occurred” might be produced. immediately after
occurrence of the error all ongoing tests are stopped. depending on open test orders the system might restart
processing using an already consumed cuvette and hence, producing a potentially erroneous result.
we have identified measures to ensure the detectability for measurements that may have yielded erroneous results.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Customers complained that individual c packs of tina-quant hba1c gen. 2 and tina-quant hba1c dx gen. 2
reagent across multiple lots yielded elevated recoveries on qc materials and patient samples.
tina-quant hba1c gen. 3 is not affected as the reagent is less sensitive to low temperature in comparison to the
tina-quant hba1c gen. 2 reagent. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Internal studies revealed a software issue which affects the urea sample measurement results. the urea recovery
for samples and qc measurement results can be both, too low or too high. all customers using any lot of mss
cassettes glu/lac/urea(bun) to test for urea on the cobas b 221 <6> instrument are affected.
to avoid any risk of reporting wrong patient sample results for the urea parameter, sample measurements have to
be measured two times until this issue is fixed in an upcoming software version, planned for january 2017.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
We regret to inform you that multiplate® analyzers used with software version 2.04.37 and software version
2.04.39 may generate a wrong reference range and target range graphical printout.
the multiplate® analyzer software contains a functionality that allows the reference range and target range to be
displayed in the form of horizontal graphical bars. when this functionality is enabled, sample result will be
displayed as a black vertical line within the reference/target range graphical bars to indicate its position relative to
the set ranges. when sample results are printed, the graphical bars and the sample result line will be printed as
well (see figure 1).
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Customers complained about a 20% decrease in control levels when using non-roche controls (e.G. thermofisher liqimmune) with homocysteine reagent lot 697811 on cobas c 501. after changing to lot 604303, the controls were within range. the comparison of patient samples with reagent lot 697811 vs 604303 showed a bias of up to 54%. edta plasma samples were used. this negative bias could, in the worst case, lead to inaccurately low homocysteine results. however, it is unlikely that inaccurately low homocysteine results would lead to an immediate adverse event, since it has been demonstrated that homocysteine is a predictor of long-term (late cardiac events), rather than short-term cardiovascular risk. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Labeling error in the cobas® egfr mutation kit, v2
and cobas® cfdna sample preparation kit .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
During internal studies using contrived plasma specimens, several mutations (l858r, exon 19 deletion, t790m)
inconsistently generated “no mutation detected” (i.E. false negative) results with the cobas® egfr mutation test,
v2 when utilizing the cobas® cfdna sample preparation kit.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Roche diagnostics received complaints from two customers that un-spun samples were incorrectly identified as
“spun” by the spin status detection on cobas p 512 (64x) pre-analytical system. when non-centrifuged samples
incorrectly identified as “spun” are further analyzed, erroneous results may occur and relevant medical risk cannot be
entirely excluded. this case made us aware that we need to provide a better specification on the intended use of the
spin status detection.
the cobas p 512 (64x) and the cobas p 612 (63x) systems are not designed to make a sorting decision based on the
spin status detection functionality. while investigating these complaints, we identified that all documentation related to
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
In the last version of this customer letter we informed you about the implementation of an instrument factor (if) for
online tdm gentamicin that was - based on available data - the mitigation for the reported issue.
however, against initial data the correction of the instrument factor did not mitigate the issue. we received
complaints from customers who implemented the if, observing decreased sample recovery using the online tdm
gentamicin assay.
since availability of fresh patient samples for gentamicin is very limited, frozen patient samples had to be used for
internal investigations. obviously, the internal results obtained with these samples and used for the implementation
of the if did not match with the external observations reported by customers. further investigations were initiated
at roche to understand this mismatch. in order to verify the internal results a new panel of patient samples was
collected (panel b, stored at -80°c) and compared to the panel that was used for the determination of the if (panel
a, stored at -20°c). .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Notas adicionales en la data
Causa
Due to an incident with one handle (cracks in welding area of handle unit, which resulted in
a breakage) decision was taken by sano to inspect handles of above defined serial numbers.
in order to keep downtime of device low, sano will send sufficient new handles to its
partners for replacement. inspection of replaced handles needs to be done by sano after
return of parts to its premises in austria.