BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 1211259 · Received October 16, 2008

    Report

    Report Number
    2954323-2008-02720
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    NBW
    Removal / Correction Number
    Z-0709-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER DID NOT CONFIRM FOR INCORRECT DATE AND TIME. HOWEVER, THERE IS A KNOWN MALFUNCTION WITH THE PRECISION LINK SOFTWARE THAT CAN LEAD TO INCORRECT DATE AND TIME ISSUES WHEN THE DATA IS UPLOADED TO A COMPUTER. THIS OCCURS WHEN RESULTS, OBTAINED ON A METER WITH INCORRECT DATE AND TIME, ARE UPLOADED TO PRECISION LINK. CUSTOMERS AND RETAILERS HAVE BEEN NOTIFIED THROUGH THE ADC FA21DEC2006 LETTER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE DATE IN THEIR PRECISION XTRA BLOOD GLUCOSE METER ARBITRARILY RESETS. IT WAS THEN ADDITIONALLY IDENTIFIED BY ADC CUSTOMER SERVICE THAT 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
    1 PRECISION LINK DATA MANAGEMENT SYSTEM NBW ABBOTT DIABETES CARE INC., USA NA 41977

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK