BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1253429 · Received December 3, 2008

    Report

    Report Number
    2939301-2008-03419
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) TO EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM, AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    UNABLE TO REACH THE PT/LAYPERSON, THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS REVIEWED THE CUSTOMER CARE ADVOCATE'S CCA'S, DOCUMENTATION AND CLASSIFIED THE COMPLAINT. THE PT ALLEGED HIS ONE TOUCH ULTRA METER PROMPTED ER2, WHEN HE TURNED ON THE METER. IN 2008, TWO WEEKS AFTER THE ALLEGED ISSUE BEGAN, THE PT REPORTEDLY DEVELOPED A DRY MOUTH AND BLURRY VISION, FOR WHICH HE TOOK "MORE INSULIN". BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED, THE CCA REPLACED THE METER AND TEST STRIPS. DUE TO THE ALLEGED SYMPTOMS, THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE REPORTED ISSUE BEGAN, THE COMPLAINT IS CLASSIFIED AS A REPORTABLE MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2678128

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening