BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1161174 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06886
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CALLER STATES THAT THE CUSTOMER EXPERIENCED AN EVENT WHERE HE OBTAINED THE BLOOD GLUCOSE RESULT OF 101 MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE CUSTOMER SUDDENLY EXPERIENCED A PAINFUL HEADACHE AND WAS TAKEN TO THE EMERGENCY ROOM. THE CALLER DID NOT DISCLOSE IF THE HEADACHE WAS INDICATIVE OF HYPOGLYCEMIA. HIS BLOOD GLUCOSE RESULT ON THE PROFESSIONAL METER WAS 59 MG/DL. THE 101 MG/DL AND 59 MG/DL RESULTS WERE OBTAINED WITHIN TEN MINUTE TIMEFRAME. SEVENTEEN MINUTES AFTER THE 59 MG/DL PROFESSIONAL METER RESULT, THE CUSTOMER'S BLOOD GLUCOSE WAS 95 MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE CUSTOMER WAS TREATED WITH ORANGE JUICE AND SUGAR. HE FELT BETTER 90 MINUTES FOLLOWING TREATMENT. NEW SYSTEM SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300663

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention