BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1801305 · Received September 21, 2007

    Report

    Report Number
    2954323-2007-17791
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 23, 2007
    Report Date
    September 21, 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 PROCESS. A F/U REPORT WILL BE FILED WHEN 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK