Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostic Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1456
  • Date
    2014-11-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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
  • Cause
    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
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA