BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 5822589 · Received July 26, 2016

    Report

    Report Number
    2954323-2016-03396
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    July 18, 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
    ES
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. SUSPECT MEDICAL DEVICE INCORRECTLY IDENTIFIED THE METER AS MEDISENSE OPTIUM IN THE INITIAL MDR 30 DAY REPORT. SUSPECT MEDICAL DEVICE HAS BEEN UPDATED TO IDENTIFY THE METER AS A PRECISION XTRA.

    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 UNKNOWN. THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER DID NOT POWER ON WITH BUTTON DEPRESSED OR WITH TEST STRIP INSERTION. BLANK SCREEN WAS OBSERVED. LIQUID CONTAMINATION WAS OBSERVED ON THE PRINTED CIRCUIT BOARD. THE COMPLAINT WAS NOT CONFIRMED.

    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.

    Additional Manufacturer Narrative · 1

    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
    476742 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 98814-65 QA2290-1280

    Patients

    Seq Age Sex Outcome Treatment
    1