BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 1041229 · Received May 8, 2008

    Report

    Report Number
    2954323-2008-01760
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 11, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    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 INFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRC 6 MESSAGE WITH THEIR PRECISION XTRA BLOOD GLUCOSE METER WHEN UPON TEST STRIP INSERTION AND THE DATE AND TIME HAD CHANGED SPONTANEOUSLY. THE CUSTOMER REPORTED USING THE PRECISION XTRA DATE MANAGEMENT SYSTEM. THERE WERE NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION LINK DATA MANAGEMENT SYSTEM NBW ABBOTT DIABETES CARE INC. NA 41943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA