BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 3052443 · Received April 11, 2013

    Report

    Report Number
    2954323-2013-00214
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ( 45001J319) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED PRODUCT WAS RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HER SON'S ADC BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 22 MMOL/L, 2 MMOL/L AND 14 MMOL/L 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
    155689 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001J319

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR