BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 SYSTEM

    MDR report key: 1019714 · Received March 24, 2008

    Report

    Report Number
    1950204-2008-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LTW
    PMA / PMN Number
    N50510
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VITEK 2 INSTRUMENT IS DESIGNED TO USE ONE LITER BAGS OF 0.45% SALINE. THE VITEK 2 PRODUCT LABELING CLEARLY STATES IN MULTIPLE LOCATIONS THAT 0.45% SALINE MUST BE USED WITH THE VITEK 2 SYSTEM. IN THIS INSTANCE, THE CUSTOMER USED ONE LITER BAGS OF DEXTROSE ON THEIR THIRD VITEK 2 INSTRUMENT BY MISTAKE. THE ONE LITER DEXTROSE BAGS WERE OBTAINED FROM THEIR OWN INVENTORY.

    Description of Event or Problem · 1

    WHILE PERFORMING THE 20/30 DAY QC ON THEIR THIRD VITEK 2 INSTRUMENT, A CUSTOMER NOTICED THAT THEY HAD BEEN USING DEXTROSE BAGS INSTEAD OF THE REQUIRED 0.45% SALINE BAGS. THE PROBLEM WAS NOTICED DUE TO QC ISSUES ON ONLY THE THIRD INSTRUMENT, WHICH HAD BEEN USED FOR MULTIPLE WEEKS. THE CUSTOMER ASSUMED THAT SENSITIVITIES WOULD BE MORE RESISTANT AND WANTED CONFIRMATION, HOWEVER, BIOMERIEUX, INC. CANNOT CONFIRM THIS ASSUMPTION. BIOMERIEUX INC. DID SUGGEST THAT THE CUSTOMER VERIFY THE SENSITIVITY PATTERNS ON TESTED ORGANISMS, REPEAT THOSE ISOLATES THAT ARE AVAILABLE, VERIFY THAT QC WAS ACCEPTABLE DURING THIS TIME AND RECOMMENDED THAT THE PHYSICIAN BE NOTIFIED OF THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK 2 SYSTEM VITEK 2 SYSTEM LTW BIOMERIEUX, INC. MULTIPLE NA

    Patients

    Seq Age Sex Outcome Treatment
    1