BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1030025 · Received April 14, 2008

    Report

    Report Number
    2939301-2008-00550
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    February 4, 2008
    Report Date
    March 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    ON MARCH 16, 2008, PT'S DAUGHTER/REPORTER CONTACTED LIFESCAN (LFS) ON LAY-USER/PT ALLEGING THAT THE ONE TOUCH ULTRA IS GIVING TWO ISSUES: METER DOES NOT TURN ON AND INACCURATE ERRATIC READINGS. THIS MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PT TO VERIFY INFO GATHERED DURING THE INITIAL CALL OR OBTAIN FOLLOW UP INFO. ON THE AFTERNOON OF 2008, THE PT OBTAINED A READING OF 37 MG/DL ON THE PARAMEDIC'S METER AND WAS TREATED WITH FOOD/BEVERAGE BECAUSE OF THE REPORTED ISSUE WITH THE LFS PRODUCT. THE REPORTER WAS UNWILLING/UNABLE TO ANSWER THE FOLLOWING QUESTIONS: DID THE CUSTOMER/PT DEVELOP ANY SYMPTOMS BEFORE, DURING, OR AFTER THE REPORTED ISSUE BEGAN? AS A RESULT OF THE REPORTED ISSUE WITH THE LFS PRODUCT, WHAT ACTIONS DID THE CUSTOMER/PT TAKE REGARDING DIABETES TREATMENT? IT WOULD HAVE BEEN HELPFUL TO OBTAIN THE FOLLOWING INFO: TESTING FREQUENCY, DIABETES MEDICATION REGIMEN, LFS METER READINGS OBTAINED PRIOR TO THE EMERGENCY SERVICES TREATMENT, FOOD INTAKE, AND CHANGES TO DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY PRIOR TO AND AFTER THE EMS TREATMENT. DURING TROUBLESHOOTING, THE REPORTER WAS NOT ABLE TO PROVIDED ANY LFS METER READINGS RELATED TO THE ALLEGED INACCURATE ERRATIC READINGS. HOWEVER, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS NOT CLEANED APPROPRIATELY, THE BLOOD SAMPLE WERE TAKEN FROM APPROVED TESTING SITES, AND REPORTED METER READINGS WAS CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE REPORTER CLAIMED THE PT RECEIVED MEDICAL INTERVENTION FROM HEALTHCARE PROFESSIONALS AND HAD A BLOOD GLUCOSE RESULT OF 37 MG/DL AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2791757

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| R