BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1970733 · Received January 25, 2011

    Report

    Report Number
    2939301-2011-00875
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Report Date
    November 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) # IS K073231. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A DAMAGED/ BROKEN DISPLAY. IN ADDITION A SECONDARY ISSUE WAS FOUND WHERE THE BATTERY CONTACT WAS CORRODED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING A DISPLAY ISSUE ON THEIR ONE TOUCH ULTRALINK METER. THE PATIENT MENTIONED THAT THERE WAS BLUE AND RED LINES ON THE DISPLAY. THE PATIENT FIRST NOTICED THE ISSUE ON (B)(6) 2010 AT 10:00AM. AT THE TIE SAME TIME THE PATIENT FELT DAZED, CONFUSED AND DIZZY. THE PATIENT ATE MORE FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT, SINCE THE SYMPTOMS ARE NOT SUGGESTIVE OF A SERIOUS INJURY. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WITH THE METER WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR