BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE TEST STRIPS

    MDR report key: 1181143 · Received September 30, 2008

    Report

    Report Number
    1823260-2008-07262
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    CALLER STATES THE PT OBTAINED A BLOOD GLUCOSE RESULT OF 9.5 MMOL/L ON THE ADVANTAGE SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THIS RESULT; PT'S DOCTOR WAS CONTACTED, AND PT WAS TREATED WITH EMERGENCY FAST ACTING INSULIN (TIMEFRAME BETWEEN SYMPTOMS AND TREATMENT IS NOT KNOWN). A RESULT OF 2.6 MMOL/L WAS OBTAINED ON THE DOCTOR'S METER 30 MINUTES AFTER INSULIN TREATMENT, AND A RESULT OF 14.6 MMOL/L OBTAINED ON THE ADVANTAGE SYSTEM IMMEDIATELY FOLLOWING THE DOCTOR'S RESULT. THE PT WAS ADMITTED TO THE HOSPITAL OVER NIGHT, AND WAS SUBSEQUENTLY TREATED WITH A BISCUIT AND ORANGE JUICE. THE PT HAS FULLY RECOVERED. SINCE LEAVING THE HOSPITAL, THE PT OBTAINED A READING OF 6.4 MMOL/L ON THE DOCTOR'S METER, AND AT THE SAME TIME THE ADVANTAGE SYSTEM GAVE A READING OF 14.8 OF MMOL/L. METER AND STRIPS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-NA NBW ROCHE DIAGNOSTICS 449855

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention