BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060281 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01043
    Event Type
    Injury
    Date Received
    June 10, 2008
    Report Date
    May 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR 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 FOLLOWING INFO WAS OBTAINED FROM THE CUSTOMER CARE ADVOCATE'S DOCUMENTATION SINCE THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE LAY USER/PATIENT FOR ADDITIONAL INFORMATION. ON MAY 17, 2008 THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE TEST WAS NOT STARTING ON HIS ONE TOUCH ULTRA METER AFTER A BLOOD SAMPLE WAS APPLIED TO THE TEST STRIP; INSTEAD, HIS METER KEPT ON DISPLAYING THE "APPLY SAMPLE" SYMBOL. THE REPORTED ISSUE FIRST OCCURRED ON TWO DAYS BEFORE AT AN UNSPECIFIED TIME (2 DAYS PRIOR TO LFS CALL). AT AN UNSPECIFIED DATE/TIME AFTER THE REPORTED ISSUE BEGAN, THE PT CLAIMED HE DEVELOPED SYMPTOMS OF BLURRED VISION IN HIS LEFT EYE AND FEELING WEIRD; HOWEVER, HE DENIED RECEIVING ANY TYPE OF MEDICAL INTERVENTION. THE PT ALSO DID NOT TEST ON ANY OTHER DEVICE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE EVENTS LEADING TO THE PATIENT'S SYMPTOMS, SUCH AS HIS PREVIOUS METER READINGS, MEALS, MEDICATIONS, ACTIVITIES. IT WOULD ALSO BE HELPFUL IF THE PT'S SYMPTOMS WERE ALLEVIATED AND HOW. THE CUSTOMER CARE ADVOCATE (CCA) WENT THROUGH THE TROUBLESHOOTING WITH THE PT AND CONFIRMED THAT THE TEST STRIPS DREW IN THE SAMPLE. THE PT RETESTED WITH A NEW VIAL OF TEST STRIPS AND THE ISSUE PERSISTED; THEREFORE, THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA OR HYPERGLYCEMIA AFTER THE "APPLY SAMPLE" ISSUE STARTED. IN ADDITION, THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening