BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHE

    MDR report key: 772804 · Received October 24, 2006

    Report

    Report Number
    MW1040786
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    October 14, 2006
    Report Date
    October 24, 2006
    Manufacturer
    ROCHE DISGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN ANOTHER COUNTRY, A ROCHE ACCU-CHEK AVIVA METER CONSISTENTLY GAVE "ERR" FOR BLOOD GLUCOSE METER. FDA HAD ISSUED A RECALL ON THIS METER. AFTER REPLACEMENT OF THE METER FROM ROCHE, THE METER CONTINUED TO GIVE "ERR" FOR BLOOD GLUCOSE METER. PROBLEM WAS TRACED TO BAD LOT OF TEST STRIPS #300232 WHICH HAVE NOT BEEN RECALLED BY ROCHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE ACCU-CHEK AVIVA GLUCOSE TEST STRIPS NBW ROCHE DISGNOSTICS NA 300232

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening