BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 5827912 · Received July 27, 2016

    Report

    Report Number
    2954323-2016-03462
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    July 20, 2016
    Report Date
    August 4, 2016
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    CGA
    PMA / PMN Number
    K983504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. LISTED THE INCORRECT PMA/510(K) # AS K040814 IN THE INITIAL MDR 30 DAY REPORT. HAS BEEN UPDATED TO IDENTIFY THE PMA/510(K) # AS K983504.

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURER DATE FOR THE REPORTED METER IS NOT VALID. THE SERIAL NUMBER DOES NOT EXIST. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    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
    479837 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM CGA ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1