BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1999688 · Received February 23, 2011

    Report

    Report Number
    2939301-2011-01603
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 13, 2011
    Report Date
    February 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K 053529. 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 ON (B)(6) 2011 ALLEGING THAT SHE WAS UNABLE TO OBTAIN A READING ON HER ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 8:45AM. DUE TO THE ALLEGED ISSUE, AN HOUR LATER SHE DEVELOPED SYMPTOMS OF FEELING SHAKY. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT WAS TESTING IN THE MEMORY MODE. THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST AND LATER 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