BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 421537 · Received April 15, 2002

    Report

    Report Number
    2939301-2002-05247
    Event Type
    Malfunction
    Date Received
    April 15, 2002
    Report Date
    April 5, 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 PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A FT METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 64, 152, 143 MG/DL. TESTS WERE DONE WITHIN >10 MINS WITH A DIFFERENC OF 43%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED. NOTE-CUSTOMER ATE FOOD AND DRANK BEVERAGE FOLLOWING USE OF METER.

    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 78 YR