BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 5942556 · Received September 12, 2016

    Report

    Report Number
    2954323-2016-04696
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 29, 2016
    Report Date
    March 22, 2017
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURER DATE FOR THE REPORTED METER IS UNKNOWN. THE DATE ENTERED IN SECTION H4 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURER DATE FOR THE REPORTED METER IS UNKNOWN. THE DATE ENTERED IN IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION AND TEST STRIP INSERTION. NO NEW ISSUES WERE OBSERVED. BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. THIS SERVES AS A CORRECTION REPORT. HAS BEEN UPDATED TO THE CORRECT CATALOG # 98814-65. ALSO PMA/510 (K) # HAS BEEN UPDATED TO K040814.

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURER DATE FOR THE REPORTED METER IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION AND TEST STRIP INSERTION. NO NEW ISSUES WERE OBSERVED. BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT WAS NOT CONFIRMED.THIS REPORT IS BEING FILED AS A CORRECTION.

    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
    596303 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 98814-65

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR