BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1051699 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04133
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MEDWATCH WITH A1 PATIENT FOR ADVANTAGE SYSTEM 1. THIS MEDWATCH IS BEING FILED FOR ADVANTAGE SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 240 MG/DL ON ADVANTAGE SYSTEM 1, 107 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. STRIPS LOT 549830 IN ADVANTAGE SYSTEM 1 FAILED CONTROLS, STRIPS LOT 551577 IN ADVANTAGE SYSTEM 2 PASSED CONTROLS. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 550577

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR VYTORIN 10/40 MG/DAY - 1.5 YEARS| COQ10 100 MG/DAY - 6 MONTHS| OMEGA 3 1200 MG/DAY| ASPIRIN 325 MG/DAY - 3 YEARS| ATENOLOL 25 MG/DAY - 3 YEARS| GLUCOPHAGE 1500 MG/DAY - 3 YEARS| CELEBREX 600 MG/WEEK - 8 MONTHS