BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCU-CHEK

    MDR report key: 2250692 · Received September 12, 2011

    Report

    Report Number
    MW5022244
    Event Type
    Other
    Date Received
    September 12, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TEST STRIPS DEFECTIVE. TEST STRIP WOULD NOT REGISTER IN GLUCOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK GLUCOMETER NBW ROCHE DIAGNOSTICS 303274
    2 AVIVA GLUCOMETER TEST STRIPS NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other