BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1220056 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08062
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS BEING SUBMITTED FOR ADVANTAGE SYSTEM 1. REFERENCE MEDWATCH WITH A1 PT FOR SUSTPECT DEVICE IN ADVANTAGE SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 148 MG/DL WITH ADVANTAGE SYSTEM 1 AND 78 MG/DL WITH ADVANTAGE SYSTEM 2 WHEN TESTS WERE PERFORMED BACK-TO-BACK. CUSTOMER REPORTED HAVING NO SYMPTOMS, AND DID NOT TREAT OR ACT BASED ON RESULTS. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. 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 550643

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR GLIPIZIDE - 5 MG TWICE DAILY| METFORMIN - 1000 MG TWICE DAILY