BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 8905380 · Received August 19, 2019

    Report

    Report Number
    2954323-2019-06334
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 14, 2019
    Report Date
    February 5, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    TO DATE, PRODUCT HAS NOT BEEN RETURNED FOR FURTHER INVESTIGATION. THE USEFUL LIFE OF XCEED METERS IS 5 YEARS. AS THE MANUFACTURING YEAR OF THIS PRODUCT IS 2013, IT HAS BEEN IN DISTRIBUTION BEYOND ITS USEFUL LIFE AT THE TIME OF THE COMPLAINT. SINCE THE PRODUCT EXCEEDED ITS USEFUL LIFE, IT IS DETERMINED TO HAVE MET SPECIFICATION WHEN THE PRODUCT WAS RELEASED AND THROUGH ITS LIFESPAN. NO FURTHER INVESTIGATION ACTIVITIES ARE BEING PERFORMED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION, BUT NOT TEST STRIP INSERTION. A PORT-2 ISSUE WAS OBSERVED. THE REPORTED COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    701692 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 98814-65

    Patients

    Seq Age Sex Outcome Treatment
    1