BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1233583 · Received November 17, 2008

    Report

    Report Number
    1823260-2008-08465
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    October 3, 2008
    Report Date
    November 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED THAT THE ADVANTAGE SYSTEM GAVE BLOOD GLUCOSE RESULTS IN THE 200-400 MG/DL RANGE AND THE CUSTOMER WAS TREATED WITH NOVOLIN BASED UPON THOSE RESULTS AT A TIME WHEN THE CUSTOMER WAS SYMPTOMATIC OF HYPOGLYCEMIA. SHE WAS TRANSPORTED TO A HOSP, WHERE HER BLOOD GLUCOSE WAS MEASURED AS 30 MG/DL. SHE WAS TREATED WITH IV GLUCOSE. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 79 YR Hospitalization| R GLIPIZIDE ER - 2.5 MG/DAY