BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 426443 · Received June 28, 2002

    Report

    Report Number
    2939301-2002-07377
    Event Type
    Malfunction
    Date Received
    June 28, 2002
    Report Date
    June 19, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    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

    A PATIENT REPORTED EXPERIENCING INACCURATE LOW RESULTS USING A LIFESCAN METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 88MG/DL (METER), 133MG/DL (LAB). TESTS WERE DONE WITHIN 11-20 MINUTES WITH A DIFFERENCE OF 34%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED. NOTE: IN THE REPORTED ISSUE NOTES IT WAS DOCUMENTED THAT, "SOLUTION TEST 144 (113-152)".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN