Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostic Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1456
  • Date
    2014-11-11
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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
  • Reason
    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.
  • Action
    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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA