BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1081608 · Received July 25, 2008

    Report

    Report Number
    2939301-2008-01519
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    July 8, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, 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, THE LAY USER/PT CONTACTED LIFESCAN ALLEGING SHE WAS SEEING PAST RESULTS ON THE ONE TOUCH ULTRA METER. THE MEDICAL AFFAIRS SPECIALIST WAS NOT ABLE TO CONTACT THE PT TO OBTAIN/CLARIFY INFO. THE PT STATED THE ISSUE BEGAN ABOUT A MONTH BEFORE SHE CALLED LIFESCAN. THE PT MENTIONS THAT SOMETIME AFTER THE ISSUE STARTED, SHE HAD SYMPTOMS OF FREQUENT URINATION. THE PT DID NOT TAKE ANY ACTION REGARDING DIABETES TREATMENT DUE TO THE ISSUE AND DENIED SEEKING MEDICAL ATTENTION. NO OTHER INFO WAS PROVIDED. THE PRODUCT WAS NOT NEW AND THE ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED SHE SAW PAST RESULTS ON HER METER, WHICH MAY HAVE DELAYED TREATMENT AND SHE REPORTEDLY HAD SYMPTOMS OF HYPERGLYCEMIA SOMETIME AFTER THE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening