BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISON XTRA/OPTIUM

    MDR report key: 1020231 · Received March 26, 2008

    Report

    Report Number
    2954323-2008-01199
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    December 13, 2007
    Report Date
    March 26, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED AN ISSUE WITH THE DISPLAY ON THEIR PRECISION XTRA BLOOD GLUCOSE METER. UPON PRODUCT INVESTIGATION, IT WAS DISCOVERED THE METER EXHIBITED A DISPLAY ISSUE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ISSUE WITH THE DISPLAY ON THEIR PRECISION XTRA BLOOD GLUCOSE METER. UPON PRODUCT INVESTIGATION IT WAS DISCOVERED THE METER EXHIBITED A DISPLAY ISSUE. 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 PRECISON XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA