BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1803177 · Received August 31, 2007

    Report

    Report Number
    2954323-2007-16281
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 31, 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 METER HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA21DEC2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR PRECISION XTRA BLOOD GLUCOSE METER IS SHOWING WRONG DATE AND TIME SETTINGS AND IS BEING USED WITH PRECISION LINK V2.6 SOFTWARE. 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 XTRA /OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK