BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 698277 · Received October 6, 2005

    Report

    Report Number
    2939301-2005-04429
    Event Type
    Malfunction
    Date Received
    October 6, 2005
    Date of Event
    July 7, 2005
    Report Date
    September 29, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER CALLED LIFESCAN (LFS) IN 2005 AND ALLEGED THAT HER METER WAS READING INACCURATELY ERRATIC. THE MEDICAL AFFAIRS SPECIALIST ATTEMPTED UNSUCCESSFULLY TO RECH THE USER FOR MORE CLINICAL INFORMATION.A LETTER WILL BE SENT AS A SECOND ATTEMPT TO REACH THE USER. THE USER OBTIANED RESULTS OF 175, 380, 158, 191, 300, AND 57 MG/DL. THESE RESLUTS WERE OBTAINED LESS THAN 10 MINUTES APART.THE USER WAS EXPERIENCING NEUROPATHY AT THE TIME OF TESTING.HER MEDICAL PROFESSIONAL TREATED HER WITH INSULIN. THE TEST STRIPS USED BY THE LAY USER WERE IN GOOD CONDITION, CODES MATCHED, AND THE TECHNIQUE FOR APPLYING THE BLOOD TO THE TEST STRIP WAS CORRECT.THE TECHNIQUE FOR CLEANING THE PUNCTURE SITE WAS NOT CORRECT.THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TO PERFORM A TEST. IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT THE USER'S BLOOD GLUCOSE WAS ON THE MEDICAL PROFESSIONAL'S METER AND IF HIS MEDICATIONS WERE ADJUSTED AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2561362

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN