BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2072290 · Received April 28, 2011

    Report

    Report Number
    2954323-2011-03093
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    July 29, 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER WAS TESTED AND CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6), 2011 A CUSTOMER REPORTED SHE RECEIVED AN ERROR-7 DISPLAY MESSAGE ON HER PRECISION XTRA GLUCOSE METER, AND ALSO THAT SHE HAD A MEDICAL EVENT WHEN SHE "BLACKED OUT" DUE TO A LOW BLOOD SUGAR, BUT DECLINED TO COMPLETE THE MEDICAL SURVEY. THERE WAS NO REPORT OF 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 45357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other