BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1220055 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08061
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 26, 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
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE RESULTS OF 280 MG/DL AND 40 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTS WERE PERFORMED BACK-TO-BACK. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. THE SUSPECTED DEVICE WAS UNAVAILABLE FOR RETURN; 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 TEST STRIPS- LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR METFORMIN - 3 YRS- 1000 MG TWICE DAILY