BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1153233 · Received September 4, 2008

    Report

    Report Number
    1823260-2008-06695
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 17, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ROCHE DIAGNOSIS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTS CUSTOMER HAD A BLOOD GLUCOSE RESULT OF 131MG/DL, WAS FEELING SHAKY AND PASSED OUT. RESULTS DID NOT MATCH SYMPTOMS. DAUGHTER REPORTS SHE CALLED THE PARAMEDICS AND THEY ARRIVED 15 MINUTES LATER AND TESTED CUSTOMER WITH A BLOOD GLUCOSE RESULT OF 28MG/DL; WAS TREATED WITH GLUCOSE IV AND TAKEN TO THE HOSPITAL. NO CONTROLS WERE RUN. 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 DIAGNOSIS 550037

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention GLUCOPHAGE 10 YEARS| NOVOLIN N 10 YEARS| NOVOLIN R 10 YEARS