BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1040971 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03844
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 8, 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 97 MG/DL AND 434 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM; ALSO REPORTED HI, WHICH ON THE COMPACT PLUS SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 141 MG/DL WITHIN 10 MINUTES, SAME 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 20667941

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR INSULIN 4 UNITS IF OVER / 201-50 1 YEAR| GLIPIZIDE 20MG/DAY / 4-5 YEARS