BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1896989 · Received November 11, 2010

    Report

    Report Number
    2939301-2010-09791
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 6, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K021819.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 A DATE AND TIME ISSUE ON HIS ONE TOUCH ULTRASMART METER. THE PATIENT MENTIONED THAT THE REPORTED ISSUE WITH THE METER BEGAN ON THE EVENING OF (B)(6) 2010. DUE TO THE ALLEGED ISSUE, THE PATIENT ATE MORE FOOD/DRINK. AN HOUR AFTER THE ALLEGED ISSUE BEGAN HE DEVELOPED SYMPTOMS OF FEELING THIRSTY. 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 MENTIONED THAT ALLEGED ISSUE OCCURRED AFTER REMOVING/REPLACING THE BATTERY. CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH TESTING AND ISSUE WAS RESOLVED OVER THE PHONE. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE DATE AND TIME ISSUE, HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3063836

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening