BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1110283 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05237
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    June 6, 2007
    Report Date
    June 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY REC'D RESULTS OF 462 MG/DL, 223 MG/DL, 155 MG/DL, AND 277 MG/DL ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. CUSTOMER REPORTEDLY TOOK 10 EXTRA UNITS OF R AND N INSULIN, HOWEVER, 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 20666241

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR N INSULIN - APPROX 3 YEARS 1400 U/DAY| R INSULIN - APPROX 3 YEARS 40 U/DAY