BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1916721 · Received December 7, 2010

    Report

    Report Number
    2939301-2010-10609
    Event Type
    Injury
    Date Received
    December 7, 2010
    Report Date
    November 11, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K053529. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ALLEGING THAT THEIR ONE TOUCH ULTRA 2 METER DID NOT POWER ON. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN ON (B)(6) 2010 AT AROUND 7:30AM. APPROXIMATELY 10 MINUTES LATER, THE PATIENT DEVELOPED SYMPTOMS OF FREQUENT URINATION. THE PATIENT DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE METER DID NOT POWER ON BY PRESSING THE POWER BUTTON. THE BATTERIES DID NOT NEED TO BE REPLACED AND THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening