BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2110763 · Received June 1, 2011

    Report

    Report Number
    2954323-2011-03458
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 1, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CUSTOMER REPORTED RECEIVING ERROR 6 AND ERROR 7 MESSAGES ON HIS PRECISION XTRA GLUCOSE METER. THE CUSTOMER REPORTED HE DID NOT FEEL WELL AND STARTED SWEATING, BUT WAS UNABLE TO TEST DUE TO THE ERROR 6 AND ERROR 7 MESSAGES ON HIS METER. HE REPORTED EXPERIENCING SYMPTOMS OF "HOT FLASHES AND SLEEPINESS". THE CUSTOMER SELF-PRESENTED TO HIS PHYSICIAN, WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH METFORMIN, WHICH HE STATED WAS A CHANGE FROM HIS NORMAL MEDICATIONS. THE CUSTOMER ALSO SELF-TREATED WITH FOOD, WATER, AND NON-DIABETES MEDICATIONS TRICOR AND ADVIL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R