Events

Alerta De Seguridad para Negative Combo Panel 50; Negative Panel Urine 51; ESBL Confirmation Panel Microscan ESBL Plus; MIC Type 38 Negative Panel; Negative Panel Urine Combo Type 55.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostic Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1456
  • Fecha
    2014-11-11
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The effect is the potential for minor clinical categorical errors for isolates of P. mirabilis and Imipenem if the new cut-off points are implemented and used in conjunction with the types of panels listed in Table 1 (see Letter to Customer). There are no other results for antimicrobials affected. This question is not specific to the batch of panels, nor is it related to a particular reading method (eg WalkAway®, autoSCAN®-4, or manual reading). Additional information: check the Letter to the Client at: http://portal.anvisa.gov.br/wps/wcm/connect/0fd9d800462a68d1bc38bfec1b28f937/Security+Security+Notification. pdf? MOD = AJPERES
  • Causa
    The technical support bulletin 190, previously made available on the company's international website, included the interpretive and revised criteria of the clinical and laboratory standardization institute (clsi) m100-s20. however, the limited performance of siemens microscan dry gram negative panels for proteus mirabilis and imipenem was not mentioned in the bulletin when using the interpretive criteria reviewed by clsi m100-s20. the performance limitation resulted in minor errors for proteus mirabilis with imipenem when compared to the frozen reference method. therefore, the drug name, cim and interpretation should not be reported for p. mirabilis and imipenem for the cim / combo microscan negative gram dry panels.
  • Acción
    Actions to be Taken by the Client: 1. Confirm receipt of this letter. Please complete the attached "Effectiveness Verification Form" and send it by e-mail to Siemens Healthcare Diagnostics; 2. TSB 190 has been filed in the Siemens Document Library. If you have a copy, please dispose of it properly; 3. If your laboratory has implemented the revised Imipenem breakpoints, the imipenem should be deleted for the reports for P. mirabilis in the panels listed in Table 1 (Customer Letter); 4. If a TSA Action and Interpretation Alert Rule was created in your LabPro system following the instructions in TSB 190, all results for P. mirabilis and Imipenem using the Gram negative Negative panels listed in Table 1 should be suppressed using the instructions on the following pages.

Device

Negative Combo Panel 50; Negative Panel Urine 51; ESBL Confirmation Panel Microscan ESBL Plus; MI...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostic Inc
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA