BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 3080503 · Received April 26, 2013

    Report

    Report Number
    2954323-2013-00243
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 30, 2013
    Report Date
    March 30, 2013
    Product Code
    NBW
    Removal / Correction Number
    Z-0709-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER DID NOT CONFIRM FOR INCORRECT DATE AND TIME. HOWEVER, THERE IS A KNOWN MALFUNCTION WITH THE PRECISION LINK SOFTWARE THAT CAN LEAD TO INCORRECT DATE AND TIME ISSUES WHEN THE DATA IS UPLOADED TO A COMPUTER. THIS OCCURS WHEN RESULTS, OBTAINED ON A METER WITH INCORRECT DATE AND TIME, ARE UPLOADED TO PRECISION LINK. CUSTOMERS AND RETAILERS HAVE BEEN NOTIFIED THROUGH THE ADC FA21DEC2006 LETTER. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING AN E6 MESSAGE ON THE DISPLAY OF THEIR PRECISION XTRA BLOOD GLUCOSE METER. IT WAS THEN ADDITIONALLY IDENTIFIED BY ADC CUSTOMER SERVICE THAT THE DATE AND TIME SETTINGS IN THEIR METER WERE NOT PROPERLY SET, AND THEY REPORTED TO BE A USER OF THE PRECISION LINK DATA MANAGEMENT SYSTEM. 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
    182831 PRECISION LINK DATA MANAGEMENT SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR