BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1860797 · Received October 7, 2010

    Report

    Report Number
    2954323-2010-01404
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 7, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT. DURING A TROUBLESHOOTING WITH ADC CUSTOMER SERVICE IT WAS IDENTIFIED THE CUSTOMER WAS USING EXPIRED TEST STRIPS. THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION. NO PRODUCT INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING AN ERR-6 MESSAGE ON THEIR PRECISION XTRA METER AND AS A RESULT, THE CUSTOMER EXPERIENCED SLURRED SPEECH, DISORIENTATION AND LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH INSULIN ON THE SCENE AND DID NOT FURTHER TRANSPORT HIM TO A HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 43085

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R