BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE STRIPS

    MDR report key: 686492 · Received March 8, 2006

    Report

    Report Number
    1823260-2006-01126
    Event Type
    Malfunction
    Date Received
    March 8, 2006
    Date of Event
    February 17, 2006
    Report Date
    February 20, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SHE TESTED AT 489MG/DL, TOOK HER DIABETIC MEDICATIONS, AND A HALF HOUR LATER SHE HAD LOE BLOOD GLUCOSE SYMPTOMS. NO ADVERSE EVENT REPORTED AND NO MEDICAL TREATMENT RECEIVED. QUALITY CONTROLS USED WERE EXPIRED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE STRIPS BLOOD GLUCOSE MONITORING CFR ROCHE DIAGNOSTICS NA 548308

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR