BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2008813 · Received March 7, 2011

    Report

    Report Number
    2939301-2011-01840
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. 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 5 MESSAGE ON THEIR ONE TOUCH ULTRA METER. THE LAY USER / PATIENT CONTACTED LFS ALLEGING AN ERROR 5 MESSAGE ON THEIR ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 6:00PM. DUE TO THE ALLEGED ISSUE, THE PATIENT DID NOT TAKE ANY ACTION. APPROXIMATELY 5 HOURS LATER THE PATIENT DEVELOPED SYMPTOMS OF SHAKINESS AND WAS SWEATY. THE PATIENT WAS TREATED WITH 8 UNITS OF INSULIN BY THEIR PHYSICIAN. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ERROR 5 MESSAGE, THEY WERE UNABLE TO TEST THEIR BLOOD GLUCOSE AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO BE TREATED WITH INSULIN BY AN HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3075788

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Life Threatening| R