BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1081825 · Received July 23, 2008

    Report

    Report Number
    2939301-2008-01484
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/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

    IN 2008, A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT AN ONETOUCH ULTRA METER HAD A DATE/TIME INCORRECT ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION SINCE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THE INCORRECT TIME AND DATE ISSUE ON THE SAME DAY AT 3 PM AFTER SHE REPLACED THE METER'S BATTERIES. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY TOOK NO ACTIONS TOWARDS HER DIABETES ROUTINE. THE PATIENT'S SYMPTOMS OF "CLAMMY AND SWEATY" ALLEGEDLY DEVELOPED AFTER THE REPORTED LFS METER ISSUE BEGAN. IT IS UNKNOWN WHETHER THE PATIENT SOUGHT ANY MEDICAL INTERVENTIONS OR MEDICAL TREATMENTS AFTER THAT. IT IS ALSO UNKNOWN WHETHER SHE TESTED HER BLOOD SUGAR BEFORE OR AFTER THE REPORTED SYMPTOMS. THIS WAS NOT A NEW OUT OF BOX PRODUCT. THE ISSUE WAS RESOLVED AFTER THE METER WAS RESET. THE PATIENT'S PRODUCTS ARE BEING REPLACED. THERE IS NO EVIDENCE OF A METER MALFUNCTION BECAUSE THE ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2824797

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening