BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 583582 · Received March 8, 2005

    Report

    Report Number
    2939301-2005-01075
    Event Type
    Malfunction
    Date Received
    March 8, 2005
    Report Date
    February 25, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    03/05. THE RETAIN TEST STRIPS INVOLVED IN THIS CASE HAS BEEN EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: TH RETAIN TEST STRIP (LOT# 1021901) HAS FAILED TESTING AND WAS ESCALATED TO CLINICAL TEST, WHERE IT ALSO FAILED. HOWEVER, THE STRIPS EXPIRED PRIOR TO TEST COMPLETION. AT THIS TIME CO CONSIDERS THIS MATTER CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTTAKE GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 1021901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN