BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760850 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06054
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 465, 254, 188 AND 193 MG/DL WHEN TESTING WAS PERFORMED 1 MINUTE APART ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549726

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HUMULIN - YRS - 10 UNITS THREE TIMES DAILY