BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 630281 · Received August 22, 2005

    Report

    Report Number
    2939301-2005-03700
    Event Type
    Malfunction
    Date Received
    August 22, 2005
    Report Date
    August 17, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CALLED LIFESCAN (LFS) IN 08/2005 AND ALLEGED THAT THEIR METER WAS READING INACCURATELY HIGH. THE PATIENT OBTAINED TWO RESULTS OF 435 AND 385 MG/DL WHILE ON THE PHONE WITH THE LFS CUSTOMER SERVICE REPRESENTATIVE. THE TESTS WERE PERFORMED WITHIN 10 MINUTES. THE RESULTS FALL WITHIN THE 20% SPECIFICATIONS. NO SYMPTOMS WERE REPORTED AT THE TIME OF TESTING. NO TREATMENT WAS REPORTED. THE REPRESENTATIVE OFFERED TO TRANSFER THE PATIENT TO EMERGENCY SERVICES, BUT THE PATIENT REFUSED. NO INJURY OR HARM WAS ALLEGED. THE TEST STRIPS WERE IN GOOD CONDITION, CODES MATCHED, AND THE TECHNIQUES FOR APPLYING THE BLOOD TO THE TEST STRIP AND FOR CLEANING THE PUNCTURE SITE WERE CORRECT. THE PATIENT PERFORMED TWO CONTROL SOLUTION TESTS, BOTH OF WHICH FAILED. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE OF THE TWO FAILED CONTROL SOLUTION TESTS AND THERE IS NO EVIDENCE OF A SERIOUS INJURY (THE RESULTS OBTAINED THE PATIENT'S METER IN THE ABSENCE OF SYMPTOMS DO NOT INDICATE A SERIOUS INJURY). REPLACEMENT TEST STRIPS HAVE BEEN SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN