BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1001765 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01656
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 27, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: 414 MG/DL, 191 MG/DL, AND 182 MG/DL. 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 20665142

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR LANTUS 20 UNITS 5:00 PM - 3-4 YEARS| APIDRA SLIDING SCALE - 3-4 YEARS