BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 3981909 · Received August 5, 2014

    Report

    Report Number
    2954323-2014-00847
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Product Code
    NBW
    PMA / PMN Number
    K040628
    Removal / Correction Number
    Z-0709-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. NOTE: THE DEVICE MANUFACTURER DATE FOR THE SUSPECT DEVICE IS UNKNOWN. 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 ADC 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
    458211 PRECISION LINK DATA MANAGEMENT SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR