BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2227504 · Received August 30, 2011

    Report

    Report Number
    2939301-2011-08371
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASMART METER WAS REVERTING BACK TO THE SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE OCCURRED ON (B)(6) 2011 AT 10:00AM. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET AND EXERCISE AND DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. EIGHT HOURS AFTER THE ALLEGED PRODUCT ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "SHAKY" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS DETERMINED THAT THE ALLEGED ISSUE OCCURRED AFTER THE BATTERIES WERE REPLACED. THE CCA NOTED THAT AFTER WALKING THE PATIENT THROUGH RESETTING THE OPTIONS, THE REPORTED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE REPORTED ISSUE BEGAN, SHE 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. 3080722

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening