BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1232147 · Received November 14, 2008

    Report

    Report Number
    1823260-2008-08429
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT SHE HAS FELT HYPOGLYCEMIC AND OBTAINED BLOOD RESULTS IN THE 300'S (MG/DL) ON THE ACCU-CHECK ADVANTAGE SYSTEM. NO REPORTED ACTIONS TAKEN OR TREATMENT RECEIVED WITH EVENT. THE CUSTOMER ALSO REPORTS THAT SHE EXPERIENCED AN EVENT WHERE SHE FELT SHAKY AND "PASSED OUT". SHE ATE CANDY AND FOOD AFTER WAKING UP. THE CUSTOMER FELT BETTER AFTER TREATMENT. HER BLOOD GLUCOSE RESULT WAS 302 MG/DL ON THE ACCU-CHECK ADVANTAGE SYSTEM FOLLOWING TREATMENT. TWENTY MINUTES LATER, THE CUSTOMER ARRIVED AT THE EMERGENCY ROOM PER PHYSICIAN'S ADVICE. HER BLOOD GLUCOSE RESULT WAS 70 MG/DL ON THE PROFESSIONAL METER. THE CUSTOMER WAS HOSPITALIZED FOR 3 DAYS. THE CUSTOMER DID NOT DISCLOSE SPECIFIC MEDICAL TREATMENT. 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 550776

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R