BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1060060 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04679
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 900 MG/DL AND 12 MG/DL ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM 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 CORP. 20678241

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR GLIPIZIDE 5 YEARS 10 MG/DAY