BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 6619096 · Received June 7, 2017

    Report

    Report Number
    1950204-2017-00179
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Report Date
    October 20, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    C1, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE STRAINS WERE NOT SUBMITTED FOR INVESTIGATION. LAB REPORTS HAVE BEEN REQUESTED BUT NEVER SUPPLIED. THIS COMPLAINT INITIATED A SITE VISIT BY THE FAS WHERE THE STRAINS WERE RUN ON THE VITEK®2 WITHOUT A PROBLEM. FAS ADDITIONALLY PROVIDED RECOMMENDATIONS WHICH INCLUDED: INCUBATION TIME OF GP CARDS GOES FROM 12 TO 48 HOURS, CHECK COLONY SIZE AND MORPHOLOGY MCFARLAND 0.5 - 0.63 CHECK THE LIST OF AGAR VALIDATED FOR GP USE ONLY ISOLATED COLONIES HAVE A DISPENSER EXCLUSIVE FOR VITEK 2C USE TO PREVENT CROSS CONTAMINATION AGAR ALOA, HEMOLYSIS AND CAMP TEST TO DIFFERENTIATED LISTERIA SPECIES. NOTE: IN THE VITEK®2 SOFTWARE VERSION 8.01, ALL IDENTIFICATIONS OF LISTERIA INNOCUA WILL DISPLAY A NOTE STATING POSSIBILITY OF LISTERIA MONOCYTOGENES, CHECK FOR BETA HEMOLYSIS. GP LOT# 2420214403 MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES OBSERVED ON THE INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED A MISIDENTIFICATION OF LISTERIA MONOCYTOGENES AS LISTERIA INNOCUA IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. THE CUSTOMER REPORTED THAT FIVE (5) ISOLATES WERE IDENTIFIED AS LISTERIA INNOCUA WITH VITEK® 2 GP AND WERE POSITIVE ON VIDAS® LMX (DETECTION AND CONFIRMATION OF LISTERIA MONOCYTOGENES). THE RESULTS WERE CONFIRMED ON PALCAM AND OTTAVIANNI AGARS AND TRADITIONAL BIOCHEMICAL TESTING WHICH IDENTIFIED LISTERIA MONOCYTOGENES. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400186 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST CARD LQL BIOMERIEUX, INC 2420214403

    Patients

    Seq Age Sex Outcome Treatment
    1