BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1040605 · Received May 9, 2008

    Report

    Report Number
    2939301-2008-00701
    Event Type
    Injury
    Date Received
    May 9, 2008
    Report Date
    April 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 CONTACTED LIFESCAN (LFS) ON APRIL 22, 2008 ALLEGING SEGMENTS WERE MISSING ON THE PATIENT'S ONE TOUCH ULTRA METER. A MEDICAL AFFAIRS CONTACTED THE PATIENT; HOWEVER, THE PATIENT REFUSED TO ANSWER ANY MORE QUESTIONS AND DISCONNECTED THE CALL. THE PATIENT MENTIONED THAT SOMETHING SPILLED ON THE METER EITHER IN ORIGINAL MONTH. SINCE THEN SHE WAS UNABLE TO READ THE LCD SCREEN. THE PATIENT TESTS APPROXIMATELY 2-3 TIMES A DAY AND CONTINUED TO TAKE HER ORAL MEDICATION ON A REGULAR BASIS. ON FIVE DAYS PRIOR TO ORIGINAL DATE AROUND 4-5:00PM, THE PATIENT ATTEMPTED TO TEST AND WAS UNABLE TO READ THE LCD SCREEN AND FELT SHAKY AT THE TIME OF TESTING. DUE TO HER SYMPTOMS SHE CONTACTED EMS. EMS ARRIVED AND TESTED HER USING THEIR METER; HOWEVER, RESULT WAS UNKNOWN. EMS ADVISED THE PATIENT TO TAKE HER USUAL DOSAGE OF MEDICATION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW HOW THE PATIENT WAS FEELING EARLIER THAT DAY AND HOW LONG THE PATIENT'S SYMPTOMS LASTED. THE PATIENT'S HEALTH CARE PROVIDER ADVISED HER TO CONTACT LFS FOR ASSISTANCE. THE METER IS NOT A NEW PRODUCT (OUT OF BOX). THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA DURING THE TIME THE ALLEGED ISSUE BEGAN. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING AND THE METER WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R