BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRA2 METER

    MDR report key: 1060322 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01072
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    May 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT'S WIFE CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT PATIENT'S ONETOUCH ULTRA2 METER WAS REVERTING TO THE SETUP MODE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE REPORTER OR THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE WIFE REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THE SAME DAY AT 2:30 PM. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT REPORTEDLY ATE FOOD AND/OR DRANK BEVERAGE. SHE ALSO MENTIONED THAT THE PATIENT WAS FEELING "OUT OF IT, NOT REALLY BEING RESPONSIVE" (NO SPECIFIC SYMPTOMS REPORTED) AFTER THE REPORTED ISSUE. THE PATIENT DID NOT RECEIVE ANY MEDICAL ATTENTION AND WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE WIFE WAS UNABLE/UNWILLING TO ANSWER IF THERE WAS ANY METER TRAUMA. IT WAS DETERMINED THAT THE ISSUE DID NOT OCCUR IMMEDIATELY AFTER REMOVING/REPLACING THE BATTERY. THE WIFE WAS WALKED THROUGH RESETTING THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED SYMPTOMS THAT COULD BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. HE DID NOT RECEIVE ANY MEDICAL ATTENTION. THE ISSUE DID NOT OCCUR AFTER A BATTERY WAS REMOVED/REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening