BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1022809 · Received March 28, 2008

    Report

    Report Number
    1823260-2008-02833
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS METER RESULTS OF 280 MG/DL AND 83 MG/DL WITHIN 10 MINS ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    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 67 YR BYETTA - 5MCG/DAY 7 OR 8 MONTHS| GLYBURIDE/METFORMIN - 5/50MG/2 DAY| BENICAR - 20MG/DAY| LIPITOR - 25MG/DAY