BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1213303 · Received October 27, 2008

    Report

    Report Number
    1823260-2008-07911
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTS THAT THE CUSTOMER WAS UNRESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE WAS 80MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE CUSTOMER USUALLY BECOMES SWEATY IF BLOOD GLUCOSE IS BELOW 70MG/DL. THE CUSTOMER WAS GIVEN ORANGE JUICE AND SUGAR WHICH SHE CONSUMED ON HER OWN. OVER 10 MINUTES LATER, THE CUSTOMER'S BLOOD GLUCOSE RESULT WAS 75MG/DL (SAME SYSTEM). THE PARAMEDICS WERE NOTIFIED. THEY TESTED THE CUSTOMER AND OBTAINED THE BLOOD GLUCOSE RESULT OF 75MG/DL ON THE PROFESSIONAL METER. THE CUSTOMER WAS TREATED WITH GLUCOSE PASTE. NO ADDITIONAL TREATMENT PROVIDED. THE RESULTS OF THE GLUCOSE PASTE UNDISCLOSED. NEW SYSTEM SENT AND RETURN REQUESTED.

    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 550072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GLYBURIDE - SEVERAL YEARS| ACTOS - 1 YEAR