BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT

    MDR report key: 7966951 · Received October 15, 2018

    Report

    Report Number
    1950204-2018-00432
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED DUE TO A MISIDENTIFICATION OF CAP SURVEY ENTEROCOCCUS FAECIUM (CAP D-B 2018, D-11) AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE VITEK® 2 GRAM POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. THE CUSTOMER STRAIN WAS NOT AVAILABLE FOR SUBMITTAL NOR WAS THE INITIAL VITEK 2 LAB REPORT SHOWING THE MISIDENTIFICATION; THEREFORE, THE INTERNAL BIOMÉRIEUX CAP STRAIN WAS TESTED. SAMPLE 911778 (BIOMERIEUX CAP STRAIN D-B 2018, D-11 STRAIN): ALL FOUR (4) VITEK GP ID CARDS TESTED RESULTED IN A VERY GOOD IDENTIFICATION OF ENTEROCOCCUS FAECIUM. VITEK® MS GAVE A CONFIRMATORY IDENTIFICATION OF ENTEROCOCCUS FAECIUM AT 99.9%. AS ENTEROCOCCUS FAECIUM WAS THE INTENDED RESULT, THE CUSTOMER'S DISCREPANCY WAS NOT REPRODUCED AND THE VITEK 2 CARDS ARE PERFORMING AS EXPECTED. WITHOUT THE CUSTOMER'S LAB REPORT SHOWING THE MISIDENTIFICATION, IT WAS NOT POSSIBLE TO EXAMINE THE BIOCHEMICAL REACTIONS TO DETERMINE POSSIBLE CAUSES FOR THE DISCREPANCY.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A MISIDENTIFICATION OF CAP SURVEY ENTEROCOCCUS FAECIUM ((B)(4)) AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE VITEK® 2 GRAM POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR A PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE CAP SURVEY STRAIN. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER; HOWEVER, THE STRAIN IS NO LONGER AVAILABLE. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED AND WILL USE BIOMÉRIEUX'S INTERNAL CAP SURVEY STRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806794 VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX INC. 2420554103 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1