BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1061050 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04707
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 380 MG/DL OR 480 MG/DL AND APPROXIMATELY 180 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 20675941

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR LEVOTHYROXINE - 12 YEARS| ESTRADIOL - 7 YEARS| ALENDRONATE - 10 YEARS| CLONAZEPAM - 10 YEARS| TRAMADOL - 2 YEARS| GLYBURIDE - 10 YEARS| LOVASTATIN - 10 YEARS| MIRTAZAPINE - 15 YEARS| DARVOCET - 10 YEARS| CYMBALTA - 5 YEARS