BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 3061011 · Received April 16, 2013

    Report

    Report Number
    2954323-2013-00227
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    METER SERIAL NUMBER (B)(4) WAS RETURNED TEST STRIP LOT 4500161094. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY, HOWEVER, NOT NEAR THE REPORT DATE.

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED RECEIVING A HIGH READING OF 120 MG/DL ON THEIR BLOOD GLUCOSE MONITOR. THE LABORATORY REFERENCE READING OF 20 MG/DL WAS RECEIVED WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163593 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 4500161094

    Patients

    Seq Age Sex Outcome Treatment
    1