BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083495 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05817
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED CUSTOMER HAD BLOOD GLUCOSE RESULT OF 110 MG/DL AND WAS UNRESPONSIVE WHILE USING THE ADVANTAGE SYSTEM. CUSTOMER'S RESULTS DID NOT MATCH SYMPTOMS. DAUGHTER REPORTS CUSTOMER'S WIFE THOUGHT CUSTOMER WAS SLEEPING; EMTS WERE CALLED AND TESTED CUSTOMER WITH A BLOOD GLUCOSE RESULT OF 28MG/DL. DAUGHTER REPORTS CUSTOMER WAS TREATED WITH A SHOT OF "GLUCOMYCIN" AND TAKEN TO THE ER. DAUGHTER REPORTS ER TESTED CUSTOMER WITH A RESULT OF 78MG/DL; WAS TREATED WITH AN IV OF UNK CONTENT. DAUGHTER REPORTS BACK TO BACK COMPARISON TO A PROFESSIONAL METER WITH RESULTS OF 128MG/DL ON THE CUSTOMER'S METER AND 38MG/DL ON THE PROFESSIONAL METER. DAUGHTER REPORTS CUSTOMER IS STILL IN THE HOSPITAL. NO CONTROL INFO WAS PROVIDED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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 78 YR Required Intervention GLYBURIDE/METFORMIN