BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION LINK

    MDR report key: 1820490 · Received August 30, 2010

    Report

    Report Number
    2954323-2010-01204
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 30, 2010
    Product Code
    NBW
    Removal / Correction Number
    Z-0709-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED INCORRECT TIME/DATE ON THE DISPLAY OF THEIR ADC BLOOD GLUCOSE METER.THE CUSTOMER ADDITIONALLY REPORTED BEING 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 45646

    Patients

    Seq Age Sex Outcome Treatment
    1