BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2003174 · Received February 28, 2011

    Report

    Report Number
    2939301-2011-01660
    Event Type
    Injury
    Date Received
    February 28, 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
    NC, 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 ON (B)(6) 2011 ALLEGING AN ISSUE WITH THE CALCODE ON THEIR ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT THEY FIRST NOTICED THE ALLEGE DISUSE ON (B)(6) 2011 AT 10:35AM. DUE TO THE ALLEGED ISSUE THE PATIENT WAS UNSUCCESSFUL IN OBTAINING A BLOOD GLUCOSE READING. APPROXIMATELY 7-10 MINUTES LATER THE PATIENT FELT SHAKY AND DID NOT TREAT THEMSELVES OR SEEK ANY MEDICAL ATTENTION. ISSUE WAS RESOLVED VIA TROUBLESHOOTING. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE REPORTED ISSUE, THEY WERE UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS 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. 2768370

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening