BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 614290 · Received July 20, 2004

    Report

    Report Number
    2939301-2004-04098
    Event Type
    Malfunction
    Date Received
    July 20, 2004
    Report Date
    July 11, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT CALLED LIFESCAN AND ALLEGED THE ONE TOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE READINGS WERE 155, 181, 177, AND 318 MG/DL, WITHIN 10 MINUTES. NOT WITHIN LIFESCAN CRITERIA FOR PRECISION, HOWEVER THE PT WAS NOT APPLYING BLOOD CORRECTLY OR CLEANING PUNCTURE SITE CORRECTLY.NO MEDICAL ATTENTION WAS RECEIVED. NO ACTION TAKEN BY THE PT FOLLOWING USE OF THE METER. THE CUSTOMER CARE REPRESENTATIVE PERFORMED TROUBLESHOOTING AND TWICE THE CONTROL SOLUTION TEST WAS NOT WITHIN RANGE. BASED ON THE INFO OBTAINED FROM THE PT THERE IS AN INDICATION THE PRODUCT MALFUNCTIONED. (CONTROL SOLUTION) THE METER AND TEST STRIPS WERE REPLACED WITH RETURN EXPECTED.

    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