BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1803168 · Received August 31, 2007

    Report

    Report Number
    2954323-2007-16267
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 31, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. HOWEVER, THE CUSTOMER STATED HE WILL NOT BE RETURNING THE METER BECAUSE THE PROBLEM HAS BEEN FIXED AND HE DOES NOT WANT ANOTHER METER SENT TO HIM. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA21DEC06 LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AFTER CALIBRATING THE METER, THE DATE CHANGED TO (B)(6) 2002 AND THE LAST READING ON HIS GRAPH SHOWED THE WRONG DATE. IN ADDITION, THE CUSTOMER REPORTED USING THE (B)(4) SOFTWARE AND THIS IS A KNOWN MALFUNCTION WITH THE SOFTWARE THAT CAUSES INCORRECT TRENDING OF GLUCOSE RESULTS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    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 41890

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK