BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 596580 · Received April 21, 2005

    Report

    Report Number
    2939301-2005-01732
    Event Type
    Malfunction
    Date Received
    April 21, 2005
    Report Date
    April 14, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FAST TAKE METER WAS READING INACCURATELY ERRATIC. THEY OBTAINED RESULTS OF 409, 192, 372, AND 325 MG/DL WITHIN 10 MINUTES OF EACH OTHER. THE PT RECEIVED NO MEDICAL ATTENTION. THE CUSTOMER CARE REPRESENTATIVE WALKED THE PT THROUGH TWO, CONSECUTIVE CONTROL SOLUTION TESTS WHICH FELL OUTSIDE OF THE SPECIFIED CONTROL SOLUTION RANGE. THE PT NEITHER ALLEGED HARM NOR EXPERIENCED INJURY OR MEDICAL INTERVENTION. BASED ON THE TWO, CONSECUTIVE FAILED QUALITY CONTROL TESTS, THERE IS AN INDICATION THAT THE PRODUCT MALFUNCTIONED AND THAT THE EVENT MEETS THE CRITERIA FOR A MEDICAL DEVICE REPORTABLE. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTTAKE GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2502288

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN