BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1033101 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03469
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    April 12, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STATES CUSTOMER WAS UNABLE TO OBTAIN A BLOOD GLUCOSE RESULT ON THE COMPACT PLUS SYS DUE TO AN ERROR WITHIN SPEC WHILE HAVING LOW BLOOD GLUCOSE SYMPTOMS. EMT'S WERE CALLED, AND RESULT ON THEIR METER WAS 48 MG/DL; CUSTOMER WAS TREATED WITH "GLUCOSE LIQUID", AND SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LANTUS 40 UNITS ONCE DAILY