BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE II TEST STRIPS

    MDR report key: 1000143 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01661
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 20, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT'S BLOOD GLUCOSE MEASURED 29.0 MMOL/L AND 31.9 MMOL/L ON THE ADVANTAGE III SYSTEM. BASED ON THESE VALUES, PATIENT REPORTEDLY SELF-TREATED WITH INSULIN (AMOUNT AND TYPE NOT PROVIDED). AN UNSPECIFIED TIME LATER, PATIENT FELT SHAKY AND WAS UNABLE TO WALK. EMERGENCY MEDICAL SERVICES WERE SUMMONED AND, UPON THEIR ARRIVAL, PATIENT'S BLOOD GLUCOSE MEASURE 6.1 MMOL/L (ON PARAMEDICS' DEVICE). REPORTER STATED THAT PATIENT WAS GIVEN LEMONADE AND JELLY BEANS. NO ADDITIONAL TREATMENT WAS RECEIVED. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 450027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention INSULIN (TYPE AND AMOUNT UNK)