BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2109895 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04498
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K062195. 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 ERROR 2 MESSAGE AND THEN AN ERROR 1 MESSAGE ON HER ONE TOUCH ULTRA METER. THE PATIENT FIRST NOTICED THE ALLEGED ERROR MESSAGE ON (B)(6) 2011 AT AROUND 6:00PM. APPROXIMATELY 3-4 MINUTES LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING WEAK AND WAS SWEATY. THE PATIENT SELF-TREATED WITH MORE FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED AND THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR MESSAGE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND SELF-TREATED WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3068172

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening