BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 652644 · Received December 5, 2005

    Report

    Report Number
    2939301-2005-05510
    Event Type
    Malfunction
    Date Received
    December 5, 2005
    Report Date
    November 28, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE LAY PATIENT CONTACTED LIFESCAN ALLEGING THAT HIS ONE TOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE PATIENT OBTAINED RESULTS OF 60 AND 140 MG/DL ON THE REPORTED METER WITHIN 10 MINUTES OF EACH OTHER; THE READINGS WERE NOT PRECISE. THE PATIENT RECEIVED NO MEDICAL ATTENTION. THE CUSTOMER SERVICE AGENT (CSA) DISCOVERED THAT THE PATIENT DID NOT CLEAN THE PUNCTURE AREA CORRECTLY, WHICH CAN CONTRIBUTE TO INACCURATE READINGS. THE CSA ALSO CONFIRMED THAT THE TEST STRIPS WERE PEELING. 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 2594175

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN