BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1170754 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06898
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: LO (LESS THAN 10 MG/DL), 186 MG/DL, AND 171 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT 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 20675341

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NOVOLOG - 14UNITS 3/DAY| LANTUS - 30UNITS 1/DAY| AVANDIA 8MG 1/DAY