Alerta De Seguridad para CELL-DYN® 3200 CS and Accessories. Registration number: 10055310797. CELL-DYN® 3200 SL and Accessories - n. registry: 10055310800

Safety alert

794

2004-07-01

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

A sample of a patient known to have leukemia was analyzed on a cell-dyn 3200 cs 110 software version 2.0 software and presented a normal wbc count and differential results without suspicious signaling. the sample was analyzed in duplicate on a different cell-dyn 3200 cs and presented normal wbc and differential results without any signaling. a manual differential showed 14% blasts. automatic differential results were not reported outside the laboratory. cell-dyn 3200 cs did not generate a blast signal in a patient sample that presented 14% blasts in the manual differential. the machine's gain settings have been checked as correct. the possible cause for software failure to display a blast signal is the presence of abnormal blast cells, which do not meet the criteria of the algorithm for generating a signal. platelet aggregation: there was a discrepancy in platelet results (plt) of two samples from a single patient due to platelet accumulation during the use of cell-dyn® 3200 cs 110, software version 2.0. the report of the first sample showed marked thrombocytopenia (plt = 34.5 k / μl) with elevated mpv (13.0 fl). the results of pl t and mpv were underlined in the sample report, indicating that the results were outside the laboratory-specific limits, but no other suspected plt signals were generated. these results were reported outside the laboratory. a second sample from the same patient was analyzed. this report showed marked thrombocytopenia (plt = 16.1 k / μl) with normal mpv (9.65 fl) and no suspected plt signal. the plt result was underlined in the report indicating that the result was outside the laboratory-specific limit. however, the revision of the blood slide in the second sample showed accumulation of plt. the second sample was then incubated at 370c for 15 minutes and analyzed in repetition. results of heated samples showed a normal plt count (plt = 343 k / μl) with normal mpv (10.5 fl) without suspicious signs. these heated sample results were reported outside the laboratory with a note indicating that the plt count may not be accurate due to the presence of platelet aggregates. this appears to be a sample related issue involving plt-specific cold agglutinin. the buildup becomes too large to be detected and therefore is not flagged. the plt results from both samples were underlined as being outside the laboratory limits, but no other suspicious signals were generated by the cell-dyn 3200. reviewing a blood smear from the second sample showed the presence of platelet aggregates. based on the data provided by the customer for the two samples in question, this may not be confirmed if the accumulations of interfering platelets meet the criteria for signal generation. the alerts generated by cell-dyn 3200 for the two samples in question were scatter data alerts; the underline of plt results that were below the limits established by the laboratory. with any scatter data alert, the laboratory protocol for review of flagged results must be followed. describe the effect that the occurrence with the product may have on the patient's health and / or the user or ability to use the product as indicated on the label: blasto signaling: the cell-dyn 3200 cs is an automatic equipment for the production of results in patient samples. in the reported failure, the apparatus does not produce a blast signal when it is present in a patient sample. blasto cells are abnormal cells, produced in hematological diseases, such as leukemia. failure to detect the presence of blast cells may cause the physician to delay the diagnosis of leukemia. this can result in complications. plaquetary aggregate: o.

Customer Letter Customer Response Protocol All customers of the CELL-DYN® 3200 CS and SL Equipment received the communication. In Brazil, the Letter to the Client was accompanied by a Response Protocol. Communication in Brazil was initiated on: March 25, 2004. ACTIONS REQUIRED It is important that the following actions be followed: Please place this important Product Information in your Cell-Dyn 3200 System Operation Manual Section 3 - Principles of Operation, subsection, Operational Messages and Data Signaling. Please follow your laboratory procedures to communicate the health institutions that are serviced by your laboratory. If the Cell-Dyn 3200 has been relocated to another laboratory, please provide a copy of this letter to them.