BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2101311 · Received May 24, 2011

    Report

    Report Number
    2954323-2011-03379
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    August 8, 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. NOTE: THE DATE OF MANUFACTURE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND NO TEST STRIP LOT WAS REPORTED WITH THIS COMPLAINT, A DEVICE HISTORY REVIEW (DHR) OF THE METER WAS REQUESTED. THE DHR FOR METER (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING HIGHER THAN FEELS READINGS ON UNSPECIFIED DATE(S) IN (B)(6) 2008 USING A PRECISION XTRA BLOOD GLUCOSE METER. READINGS AND STRIP LOT INFORMATION WERE NOT AVAILABLE. THE CUSTOMER FURTHER REPORTED ON AN UNSPECIFIED DATE IN (B)(6) 2008, WHILE VISITING A FRIEND IN THE HOSPITAL AND AFTER EATING A MEAL IN THE CAFETERIA, HE EXPERIENCED SYMPTOMS OF SWEATING AND DIZZINESS FOLLOWED BY A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED ON THE SCENE WITH UNSPECIFIED INTRAVENOUS FLUIDS. THERE WAS NO DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    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