BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1780606 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08465
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 10, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 256 MG/DL AND 126 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 20661341

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR AMARYL 2MG HALF TAB 1/DAY - 4 YEARS