BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1063782 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04847
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 19, 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 REPORTED METER RESULTS OF 442 MG/DL, 106 MG/DL, AND 92 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, REPORTED SELF TREATMENT. 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 20675641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR GLIPIZIDE - 10MG/DAY| METFORMIN - 2000MG/DAY