BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780571 · Received September 26, 2007

    Report

    Report Number
    1823260-2007-08422
    Event Type
    Malfunction
    Date Received
    September 26, 2007
    Date of Event
    September 6, 2007
    Report Date
    September 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING HIGH BLOOD GLUCOSE RESULTS FOR TWO WEEKS ON HER ADVANTAGE SYSTEM AND WHEN GOING TO A ROUTINE DOCTOR APPOINTMENT OBTAINED DISCREPANT COMPARATIVE VALUES. REPORTER STATED OBTAINING A GLUCOSE RESULT OF 263 MG/DL ON HER SYSTEM COMPARED TO THE DOCTOR'S MEASUREMENT OF 104 MG/DL WHEN TESTING WAS PERFORMED WITHIN 5 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 549203

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR