BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP ID TEST KIT

    MDR report key: 6192925 · Received December 21, 2016

    Report

    Report Number
    1950204-2016-00209
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    April 18, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED A MISIDENTIFICATION OF ENTEROCOCCUS FAECIUM AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE VITEK® 2 GP ID TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED ISOLATING THE STRAIN FROM DALYNN COLOREX VRE AGAR AND SUBBING TO TSAB (OXOID) BEFORE TESTING. NO OTHER SET UP PARAMETERS WERE PROVIDED. THE STRAIN WAS SENT TO A REFERENCE LAB, WHICH PROVIDED THE IDENTIFICATION OF E. FAECIUM. TWO (2) LAB REPORTS WERE SUBMITTED. ONE (1) SHOWED AN EXCELLENT IDENTIFICATION OF E. GALLINARUM WITH 3 ATYPICAL POSITIVE REACTIONS (AMY, BGURR, DRAF) FOR AN IDENTIFICATION OF E. FAECIUM ACCORDING TO THE GP KNOWLEDGE BASE. ONE (1) SHOWED A VERY GOOD IDENTIFICATION OF E. FAECIUM. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS OR AN ATYPICAL STRAIN. HOWEVER WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MIS-IDENTIFICATION. ON 21FEB2017 GP LOT 242399410 MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED A MISIDENTIFICATION OF ENTEROCOCCUS FAECIUM AS ENTEROCOCCUS GALLINARUM IN ASSOCIATION WITH THE VITEK 2 GP ID TEST KIT. THE SAMPLE WAS A RECTAL SWAB FOR VRE (VANCOMYCIN RESISTANT ENTEROCOCCI) TESTING AND WAS INITIALLY IDENTIFIED AS ENTEROCOCCUS GALLINARUM 96%. THE CUSTOMER SENT THE SAMPLE TO A REFERENCE LAB FOR VANCOMYCIN CONFIRMATION WHERE THE LAB REPEATED IDENTIFICATION TESTING, AND THE RESULT WAS ENTEROCOCCUS FAECIUM. THE CUSTOMER THEN REPEATED IDENTIFICATION TESTING WITH A SUBCULTURE AND THE VITEK 2 GP ID AND THE RESULT WAS ENTEROCOCCUS FAECIUM 94%. THE TEST WAS FOR SCREENING AND THE PATIENT WAS NOT UNDER TREATMENT. THE PATIENT WAS REPORTED AS HAVING ENTEROCOCCUS GALLINARUM WITH INCREASED RESISTANCE TO VANCOMYCIN INSTEAD OF ENTEROCOCCUS FAECIUM VRE. THE PATIENT WAS DISCHARGED BY THE TIME THE RESULTS CAME BACK FROM THE REFERENCE LABORATORY SO THE PHYSICIAN WAS NOT NOTIFIED OF THE CORRECT RESULT. THE CORRECTED REPORT WAS SUBMITTED TO THE HEALTH UNIT AS WELL AS INFECTION CONTROL. 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. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844466 VITEK® 2 GP ID TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX INC. 242399410

    Patients

    Seq Age Sex Outcome Treatment
    1