BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1802318 · Received October 5, 2007

    Report

    Report Number
    2954323-2007-18832
    Event Type
    Malfunction
    Date Received
    October 5, 2007
    Date of Event
    September 6, 2007
    Report Date
    October 5, 2007
    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

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. 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. THE METER IS EXHIBITING SIGNS OF DAMAGED DISPLAY. 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 42129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA