BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1781032 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06527
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 90 MG/DL AND 43 MG/DL WITHIN 10 MINUTES ON THE COMPACT SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS REPORTED WITH THESE RESULTS; ABLE TO SELF TREAT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 20652543

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GLUCOVANCE - 850 MG 3/DAY LONG TIME| NOVOLIN N - 12 UNITS BEDTIME LONG TIME| COUMADIN - DOSE VARIES 2003 OR 2004| HUMALOG - SLIDING SCALE LONG TIME