BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040143 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03729
    Event Type
    Injury
    Date Received
    May 2, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTS AN INCIDENT OF HYPOGLYCEMIA REQUIRING PROFESSIONAL MEDICAL TREATMENT. A METER RESULT OF 197 MG/DL ON THE ADVANTAGE SYSTEM WHEN THE CUSTOMER WAS SYMPTOMATIC OF HYPOGLYCEMIA RESULTED IN A DELAY IN TREATMENT AND A SERIOUS INJURY THAT WAS TREATED WITH IV GLUCOSE AND FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549930

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention "LANTUS U100" SLIDING SCALE UNK