BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1994085 · Received February 16, 2011

    Report

    Report Number
    2939301-2011-01416
    Event Type
    Injury
    Date Received
    February 16, 2011
    Report Date
    February 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AN UNSPECIFIED INTERMITTENT ERROR MESSAGE ON HER ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN 3-4 MONTHS AGO. THE PATIENT CONTINUED TO TAKE HIS USUAL DOSAGE OF MEDICATION. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN THE PATIENT BEGAN TO SWEAT AND DENIED SEEKING ANY MEDICAL ATTENTION OR CONTACTING THEIR PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE ALLEGED ISSUE WAS RESOLVED VIA TROUBLESHOOTING. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER GIVING AN UNSPECIFIED ERROR MESSAGE, SHE WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOM 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. 2943409

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening