BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 370055 · Received December 19, 2001

    Report

    Report Number
    2939301-2001-01569
    Event Type
    Malfunction
    Date Received
    December 19, 2001
    Report Date
    November 26, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A FASTTAKE METER. THE BLOOD GLUCOSE RESULTS WERE 158, 259, 193, 279 AND 199 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57646 FASTTAKE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR