BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1110229 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05150
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 18, 2007
    Report Date
    June 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTEDLY OBTAINED RESULTS OF 230 MG/DL AND 84 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 20665141

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR LIPITOR - 4 YEARS 80 MG/DAY| TRICOR - 4 YEARS 145 MG/DAY| TRIPELINE - 1 YEAR 50 MG/DAY| ORPHENADRINE - 100 MG/DAY| NOVOLIN N - 45 U/DAY| NOVOLIN R - 15 U/DAY