BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2114794 · Received June 6, 2011

    Report

    Report Number
    2939301-2011-04574
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. METER CAME BACK FOR TESTING AND PASSED TESTING. PATIENT'S COMPLAINT WAS NOT CONFIRMED. THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING THAT THEY WERE UNABLE TO OBTAIN A READING ON THEIR ONE TOUCH ULTRA METER. THE PATIENT FIRST NOTICED THE ALLEGED ISSUE ON (B)(6) 2011. AN HOUR AFTER ATTEMPTING TO TEST THE PATIENT DEVELOPED SYMPTOMS OF FEELING SWEATY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE DUE TO THE ALLEGED ISSUE. WHILE TROUBLESHOOTING THE CUSTOMER CARE ADVOCATE (CCA) NOTICED THAT THE PATIENT WAS TESTING IN THE MEMORY MODE OF THE METER. CCA WALKED THE PATIENT THROUGH A PROPER TEST AND THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SINCE THEY WERE UNABLE TO TEST THEIR BLOOD GLUCOSE AN HOUR LATER THEY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2947758

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening