BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1002107 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01728
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES, THAT SHE OBTAINED THE BLOOD GLUCOSE COMPARISON OF 156 MG/DL AND 62 MG/DL ON THE ACCU-CHEK COMPACT METER WITHIN 10 MINS. NO REPORTED ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT THE CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR GLIPIZIDE 10 MG/DAY 3YRS| METFORMIN 1000 MG/DAY 5 YRS