BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 757522 · Received October 13, 2005

    Report

    Report Number
    2939301-2005-04535
    Event Type
    Malfunction
    Date Received
    October 13, 2005
    Report Date
    October 7, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D 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 LAY USER/PATIENT CONTACTED LIFESCAN IN 10/07/05 ALLEGING THAT THIS ONE TOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE PT REPORTED BLOOD GLUCOSE RESULTS OF "109 MG/DL AND 67 MG/DL" WITH THE LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION. THE CUSTOMER CARE AGENT (CCQ) VERIFIED THAT THE PT WAS USING THE CORRECT TESTING TECHNIQUES. THE TEST STRIPS WERE WITHIN EXPIRATION DATE, STORED PROPERLY, AND NOT OPENED LONGER THAN THE DISCARD DATE. THE CALIBRATION CODE AND UNIT OF MEASUREMENT WERE SET CORRECTLY. THE CCA WALKED THE PT THROUGH THREE CONSECUTIVE CONTROL SOLUTION TESTS AND THE FIRST RESULT WAS AN ERROR 5, WHILE THE SECOND AND THIRD RESULTS FELL OUTSIDE THE SPECIFIED RANGE. DUE TO THE FAILED QUALITY CONTROL TESTS, THIS COMPLAINT IS BEING REPORTED. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2564464

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR