BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 1001627 · Received February 7, 2008

    Report

    Report Number
    2954323-2008-00731
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    January 9, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A KNOWN MALFUNCTION WITH THE PRECISION LINK SOFTWARE. INCORRECT TRENDING OF RESULTS CAN OCCUR WHEN RESULTS OBTAINED ON A METER SET WITH INCORRECT DATE AND TIME ARE UPLOADED TO A COMPUTER. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA21DEC2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DATE AND TIME SET IN THEIR PRECISION XTRA BLOOD GLUCOSE HAD CHANGED SPONTANEOUSLY. THIS IS A KNOWN MALFUNCTION WITH THE SOFTWARE THAT CAUSES INCORRECT TRENDING OF GLUCOSE RESULTS. THE CUSTOMER REPORTS USING THE PRECISION LINK SOFTWARE. THERE WAS 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 LIMITED UK NA 99838

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK