BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1111569 · Received August 13, 2008

    Report

    Report Number
    1823260-2008-06171
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S SON-IN-LAW REPORTS BACK TO BACK TESTING TO A PROFESSIONAL METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 148 MG/DL ON THE CUSTOMER'S METER AND 27 MG/DL ON THE PROFESSIONAL METER. SON-IN-LAW REPORTS CUSTOMER WAS FOAMING AT THE MOUTH AND SLURRING HER WORDS; WAS TREATED WITH A SHOT OF GLUCOSE AND FELT BETTER ALMOST IMMEDIATELY. METER RESULTS DID NOT MATCH CUSTOMER'S SYMPTOMS. NO QUALITY CONTROLS WERE RUN. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PROD 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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GLUCOPHAGE TWO DAYS| GLIPIZIDE