BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1212113 · Received October 24, 2008

    Report

    Report Number
    2939301-2008-02804
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 6, 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

    IN 2008, A PATIENT/LAYPERSON CONTACTED LFS AND ALLEGED THAT HER ONETOUCH ULTRA METER WOULD NOT TURN ON. REPORTEDLY, THE PATIENT HAD NOT CHANGED THE BATTERY ACCORDING TO THE OWNER'S MANUAL AND WAS USING TEST STRIPS WITH A 2/2007 EXPIRATION DATE. THE PATIENT DID NOT HAVE A NEW BATTERY TO TROUBLESHOOT. AFTER THE ALLEGED ISSUE BEGAN AT 11A.M ON TWO DAYS EARLIER, THE PATIENT TOOK HER USUAL DOSE OF GLUCOPHAGE AND GLUCOTROL. AT A TIME NOT SPECIFIED AFTER THE ALLEGED ISSUE, THE PATIENT HAD "LOW SYMPTOMS". THE PATIENT DID NOT DESCRIBE THE SPECIFIC TYPE. MEDICAL INTERVENTION WAS NOT REPORTED. THE PRODUCTS WERE REPLACED. BECAUSE THE PATIENT HAS NOT RESPONDED TO CALLS MADE BY THIS SENIOR MEDICAL AFFAIRS SPECIALIST, A LETTER WILL BE SENT. IT IS UNCLEAR WHETHER THE PATIENT HAS BEEN TESTING DUE TO THE AGE OF THE STRIPS. HOWEVER, DUE TO ALLEGEDLY "LOW SYMPTOMS" AFTER THE ISSUE BEGAN, 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 2591317

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening