BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 467077 · Received June 19, 2003

    Report

    Report Number
    1823260-2003-00142
    Event Type
    Injury
    Date Received
    June 19, 2003
    Date of Event
    June 9, 2003
    Report Date
    June 11, 2003
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER USED THE DEVICE TO CHECK THEIR BLOOD GLUCOSE AND OBTAINED A RESULT OF 447 MG/DL. BASED UPON THE RESULT THEY ADMINISTERED AN EXTRA 10 UNITS OF INSULIN. THEY DIDN'T FEEL WELL LATER AND TOOK FOUR MORE TESTS AND OBTAINED THE FOLLOWING READINGS - 181, 140, 305 AND 201 MG/DL. SPOUSE CALLED THE AMBULANCE AND WHEN THE EMTS ARRIVED THEY CHECKED THEIR GLUCOSE ON THEIR METER AN THE LEVEL WAS 31 MG/DL. CUSTOMER RECALLED GETTING A GLUCOSE IV, THEY SAID THEY RAN CONTROLS ON THE SYSTEM A FEW WEEKS AGO AND ALL CONTROLS FELL WITHIN RANGE. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS CORP. NA 546433

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention