BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA / OPTIUM

    MDR report key: 1001668 · Received February 15, 2008

    Report

    Report Number
    2954323-2008-00836
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 16, 2008
    Report Date
    February 15, 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. THE CUSTOMER REPORTED EXPERIENCING THE FOLLOWING SYMPTOMS: WEAKNESS, DIZZINESS AND CONFUSION. ALTHOUGH THE CUSTOMER REPORTED BEING DIAGNOSED WITH SEVERE HYPERGLYCEMIA, HER DOCTOR JUST CHANGED HER REGULAR DIABETES MEDICATION DOSAGE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT 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 42273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA