BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 4123595 · Received September 26, 2014

    Report

    Report Number
    2954323-2014-00992
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 2014
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS.THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION. ADDITIONALLY, THE REPORTED READINGS WERE FOUND IN THE DEVICE'S INTERNAL MEMORY LOG WITHIN 10 MINUTES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 401 MG/DL AND 121 MG/DL 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
    599964 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 4500162240

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR