BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060491 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01079
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 29, 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 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 COMPLAINT IS CLASSIFIED BASED UPON INFO THE CUSTOMER CARE ADVOCATE, CCA, OBTAINED FROM THE PT/LAYPERSON IN 2008. THE PT COMPLAINED THAT AFTER REPLACING THE BATTERY IN HER ONETOUCH ULTRA METER AT 9 A.M. MAY 27TH, THE METER REPORTEDLY DISPLAYED THE TIME WHEN SHE INSERTED THE TEST STRIP. FOLLOWING THIS, THE PT THEN REPORTEDLY TOOK ONLY HER DAILY TABLET OF GLYBURIDE. AFTER THE ALLEGED ISSUE BEGAN, THE PT REPORTEDLY EXPERIENCED HUNGER, SWEATS, BLURRED VISION AND THIRST. REPORTEDLY NO MEDICAL INTERVENTION WAS RECEIVED. BECAUSE THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS BEEN UNABLE TO REACH THE PT, A LETTER WILL BE SENT. AS THE PT REPORTEDLY COULD NOT OBTAIN A READING DUE TO THE REPORTED ISSUE AND CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA OR HYPOGLYCEMIA, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2516513

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening