BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1955363 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00317
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. G5: 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART METER DISPLAY IS FADING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6), 2010. THE PATIENT INDICATED HE MANAGES HIS DIABETES WITH INSULIN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS DIABETES MANAGEMENT REGIMEN. A COUPLE OF HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT STATED HE DEVELOPED SYMPTOMS OF RAPID HEARTBEAT AND A HEADACHE. IN SPITE OF THE SYMPTOMS, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. IT IS NOT CLEAR IF THE PATIENT COULD TEST DUE TO THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT HAD USED THE SUBJECT METER BEFORE AND THERE WAS NO MISUSED OF THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2947328

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening