BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1012490 · Received March 12, 2008

    Report

    Report Number
    2954323-2008-01051
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    December 6, 2007
    Report Date
    March 12, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT TESTING ON THE RETURNED METER CONFIRMED A DISPLAY ISSUE. DAMAGED DISPLAY MAY OCCUR WHEN THE METER IS DROPPED RESULTING IN PAD FAILURES THAT CAUSE SPECIFIC AREAS OF THE METER'S LCD SCREEN TO BE UNREADABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA17AUG2007 LETTER.

    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 PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 42505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA