BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2101274 · Received May 24, 2011

    Report

    Report Number
    2954323-2011-03378
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 24, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE DID NOT INVOLVE A PRODUCT MALFUNCTION. SINCE THE MEDICAL EVENT WAS RELATED TO A TRAINING ISSUE, NO INVESTIGATION OF THE PRODUCT IS REQUIRED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN REQUESTING A CODING TRAINING WITH HIS PXTRA METER AND REPORTED AS A RESULT OF BEING UNABLE TO TEST, HE EXPERIENCED WEAKNESS AND SUBSEQUENTLY LOST CONSCIOUSNESS. NO SELF-TREATMENT OR THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. 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 47017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other