BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1771092 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01209
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 20, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER OBTAINED THE FOLLOWING BLOOD GLUCOSE COMPARISONS ON THE ACCU-CHEK COMPACT PLUS SYSTEM: 39MG/DL AND 96MG/DL; 96MG/DL AND 31 MG/DL; 126MG/DL AND 71MG/DL. ALL AFOREMENTIONED TESTS WERE OBTAINED WITHIN 10 MINUTES. NO REPORTED ACTIONS TAKEN BASED ON THE BLOOD GLUCOSE RESULTS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT AND RETURN REQUESTED.

    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 20673243

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR LANTUS - 10 UNITS/DAY| NOVOLOG - 12 UNITS/DAY| NOVOLIN NPH - 6 UNITS/DAY| NASONEX PRN