BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1212114 · Received October 24, 2008

    Report

    Report Number
    2939301-2008-02803
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 5, 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 AND STRIPS OF EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HIS ONE TOUCH ULTRA METER WAS REVERTING TO THE SETUP MODE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THE SAME DAY AT 11:00 AM . AS A RESULT OF THE REPORTED ISSUE, HE DID NOT TAKE ANY ACTIONS. THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE AT THE TIME OF CONCERN. HE STATED THAT BECAUSE HE COULD NOT USE HIS METER, HE WENT TO THE EMERGENCY ROOM AND WAS ADMINISTERED IV GLUCOSE. HE DID NOT PROVIDE HIS BLOOD GLUCOSE RESULT OBTAINED ON THE ER METER. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT AND THAT THERE WAS NOT METER TRAUMA. IT WAS DETERMINED THAT THIS ISSUE OCCURRED IMMEDIATELY AFTER REMOVING/REPLACING THE BATTERY, THE PATIENT WAS WALKED THROUGH AND TRAINED ON HOW TO SET THE DATE/TIME IN THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT HE RECEIVED IV GLUCOSE TREATMENT AT THE EMERGENCY ROOM SINCE HE WAS NOT ABLE TO USE THE SUBJECT METER. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF CONCERN. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2643060

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening