BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPLETE

    MDR report key: 1022516 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02914
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 22, 2000
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K973662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED BLOOD GLUCOSE RESULT OF LO (LESS THEN 10 MG/DL) ON THE COMPLETE SYS. AN UNK AMOUNT OF TIME LATER, CUSTOMER REPORTS BEING UNABLE TO OBTAIN BLOOD GLUCOSE RESULT ON THE COMPLETE SYS WHILE HAVING LOW BLOOD GLUCOSE SYMPTOMS. EMT'S ATTEMPTED TO USE THE CUSTOMER'S METER, BUT WERE UNABLE TO OBTAIN A RESULT (IT IS NOT KNOWN IF THE METER PRODUCED AN ERROR OR A RESULT OF LO). CUSTOMER'S BLOOD GLUCOSE RESULT ON EMT'S METER WAS 12 MG/DL AND SHE WAS TREATED WITH IV GLUCOSE; 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 COMPLETE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention LANTUS 15 UNITS ONCE DAILY| NOVOLOG SLIDING SCALE