BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 7148089 · Received December 27, 2017

    Report

    Report Number
    1950204-2017-00481
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Report Date
    May 30, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQM
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF VIBRIO CHOLERAE AS VIBRIO PARAHAEMOLYTICUS FOR A STOOL ISOLATE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED; HOWEVER, THE CUSTOMER'S STRAIN WAS NOT AVAILABLE FOR INVESTIGATION AND SET UP INFORMATION WAS NOT PROVIDED. A LAB REPORT FROM A FILMARRAY GI PANEL SHOWED THAT BOTH VIBRIO CHOLERAE AND ENTEROPATHOGENIC E. COLI HAD BEEN DETECTED. THE ISOLATE WAS SENT TO THE CUSTOMER'S STATE LAB WHO REPORTED THAT NO SPECIES OF VIBRIO WAS FOUND. ONE PARTIAL QUALITY CONTROL (QC) REPORT FOR E. HORMAECHEI ATCC 700323 AND S. MALTOPHILIA ATCC 1766 WAS SUBMITTED. THREE (3) VITEK 2 LAB REPORTS WERE SUBMITTED WITH TWO (2) SHOWING AN EXCELLENT IDENTIFICATION OF V. PARAHAEMOLYTICUS AND ONE (1) SHOWING A VERY GOOD IDENTIFICATION OF V. FLUVIALIS. HOWEVER, WITHOUT A DEFINITIVE REFERENCE IDENTIFICATION, IT IS NOT POSSIBLE TO DO AN ANALYSIS FOR ATYPICAL REACTIONS AND NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. WITHOUT THE STRAIN OR RAW DATA IT IS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. VITEK 2 GN TEST KIT LOT # 2410221403 MET FINAL QC RELEASE CRITERIA AND PASSED INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF VIBRIO CHOLERAE AS AS VIBRIO PARAHAEMOLYTICUS FOR A STOOL ISOLATE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER REPORTED THE ORGANISM WAS IDENTIFIED AS VIBRIO CHOLERAE USING FILMARRAY® AND VIBRIO PARAHAEMOLYTICUS USING THE VITEK® 2 GN CARD. THE TESTS WERE REPEATED AND PRODUCED THE SAME RESULTS. THE CUSTOMER STATED THE SPECIMEN WAS SUBCULTURED TO STOOL MEDIA INCLUDING TCBS (THIOSULFATE CITRATE BILE SALTS SUCROSE) MEDIA THAT IS SPECIFICALLY FOR VIBRIO. THE ISOLATE GREW ON THIS MEDIA AND WAS SUBCULTURED TO BAP (BLOOD AGAR PLATES), THEN TESTED ON VITEK® 2 GN. THE ISOLATE WAS 24 HOURS OLD AND INCUBATED AT 37°C IN NON-CO2. 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
    927067 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX, INC 2410273403

    Patients

    Seq Age Sex Outcome Treatment
    1