BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1792123 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06388
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2010 ALLEGING AN APPLY SAMPLE MESSAGE ON HIS ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT THE REPORTED ISSUE BEGAN APPROXIMATELY 3 MONTHS AGO. THE PATIENT HAS BEEN UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO THE ALLEGED ISSUE. THE PATIENT DID NOT CHANGE HIS DIABETES MEDICATION DUE TO THE ALLEGED ISSUE. ON (B)(6) 2010 THE PATIENT FELT SHAKY, WEAK IN THE LEGS AND WAS SWEATING. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PATIENT WAS USING THE CORRECT TEST STRIPS. WHILE TROUBLESHOOTING IT WAS NOTED THAT THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS INCORRECT. THE PATIENT WAS APPLYING THE BLOOD ON THE SIDE OF THE TEST STRIPS. ISSUE WAS RESOLVED VIA TRAINING. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE APPLY SAMPLE MESSAGE, HE WAS UNABLE TO TEST FOR ABOUT 3 MONTHS AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3024224

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening