BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 1771058 · Received June 19, 2007

    Report

    Report Number
    2954323-2007-10752
    Event Type
    Malfunction
    Date Received
    June 19, 2007
    Date of Event
    May 16, 2007
    Report Date
    June 19, 2007
    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

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA21DEC2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 6 IN THEIR PRECISION XTRA BLOOD GLUCOSE METER. THE CUSTOMER THEN REPORTED THE DATE AND TIME SETTINGS IN THEIR METER WERE NOT SET CORRECTLY, AND THEY ADDITIONALLY REPORTED BEING A USER OF THE PRECISION LINK DATA MANAGEMENT SYSTEM. THIS IS A KNOWN MALFUNCTION WITH THE SOFTWARE THAT CAUSES INCORRECT TRENDING OF GLUCOSE RESULTS. 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 40840

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK