BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 404971 · Received July 10, 2002

    Report

    Report Number
    2939301-2002-07612
    Event Type
    Malfunction
    Date Received
    July 10, 2002
    Report Date
    July 1, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A LIFESCAN METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 107MG/DL, 175MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 43%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED. NOTE: IN THE POTENTIAL MEDICAL TAB IT WAS DOCUMENTED THAT, "DIABETIC EDUCATOR PERFORMED CONTROL SOLUTION TEST USING THE ULTRA CONTROL SOLUTION AND RESULTS TESTED WITHIN RANGE AT 231/180-265 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR