BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770594 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09326
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 114 MG/DL AND 67 MG/DL BACK TO BACK WITHIN 10 MINUTES WHILE USING THE ADVANTAGE SYSTEM. CUSTOMER REPORTED HE DID NOT EXPERIENCE ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS. NO ACTION OR TREATMENT RESULTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549625

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR NOVOLIN, 9 MONTHS - 75 UNITS AM/45 UNITS PM