BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 4130529 · Received September 30, 2014

    Report

    Report Number
    2954323-2014-00999
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 1, 2014
    Product Code
    NBW
    PMA / PMN Number
    K040628
    Removal / Correction Number
    Z-0709-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A KNOWN MALFUNCTION WITH THE PRECISION LINK SOFTWARE THAT CAN LEAD TO INCORRECT TRENDING OF RESULTS. THIS OCCURS WHEN RESULTS, OBTAINED ON A METER WITH INCORRECT DATE AND TIME, ARE UPLOADED TO A COMPUTER WITH PRECISION LINK SOFTWARE. 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 HIS ADC BLOOD GLUCOSE METER. IT WAS THEN ADDITIONALLY IDENTIFIED BY ADC CUSTOMER SERVICE THAT THE DATE AND TIME SETTINGS IN THE METER WERE NOT PROPERLY SET, AND HE 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
    609046 PRECISION LINK DATA MANAGEMENT SYSTEM NBW 4500163642

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR