BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 466529 · Received June 11, 2003

    Report

    Report Number
    2939301-2003-03931
    Event Type
    Malfunction
    Date Received
    June 11, 2003
    Report Date
    June 7, 2003
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED ALLEGING THAT THEY WERE OBTAINING ERRATIC READINGS ON THEIR BLOOD GLUCOSE MONITOR. PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. COMPARISON THAT WAS MADE WAS GREATER THAN 30 MINUTES. PATIENT VISITED MD AND WAS NOT TREATED AT THE MD'S OFFICE. PATIENT CALLED LFS AND REPRESENTATIVE DID A CTRL SOL TEST ON SUBJECT VIAL OF STRIP TWICE AND IF FELL OUT OF RANGE. READINGS THAT WERE OBTAINED WERE 250, 357(107-145). PATIENT OPENED A NEW VIAL OF TEST STRIPS AND USED SUBJECT CONTROL SOULTION AND TEST STRIPS FEEL WITHIN RANGE. MEDICAL AFFAIRS IS DOCUMENTING THIS CASE AS A STRIP MALFUNCTION, SINCE TEST STRIPS FAILED CONTROL TEST TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA 1017841

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR