BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 513709 · Received February 26, 2004

    Report

    Report Number
    1823260-2004-00090
    Event Type
    Injury
    Date Received
    February 26, 2004
    Report Date
    February 17, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER USES THE DEVICE TO CHECK THEIR BLOOD GLUCOSE. THEY SAID THE DEVICE READS ERRATIC AND PT PASSES OUT DUE TO HYPOGLYCEMIA, USUALLY AROUND LUNCH TIME. THEY TAKE THEIR NORMAL DOSES OF INSULIN AS PRESCRIBED AND THE DEVICE READS THEIR GLUCOSE BETWEEN 39 AND 390 MG/DL. PT DOESN'T FEEL HYPOGLYCEMIC OR HYPERGLYCEMIC. WHEN PT PASSES OUT, FAMILY MEMBER GIVES PT ORANGE JUICE, THEN PT TENDS TO GET GLUCOSE RESULTS IN THE 330-390 MG/DL RANGE. LEVEL 1 AND LEVEL 2 CONTROLS ARE IN RANGE ON THE SYSTEM. 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 546552

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening