BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 7083047 · Received December 5, 2017

    Report

    Report Number
    1950204-2017-00428
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Report Date
    February 21, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQM
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT (CARD). THE ORGANISM WAS REPORTED AS AEROMONAS SPECIES. THE STRAIN WAS IDENTIFIED BY MALDI-TOF AS PSEUDOMONAS AERUGINOSA . BIOMÉRIEUX INVESTIGATION WAS CONDUCTED; HOWEVER, THE STRAIN, LAB REPORT AND RAW DATA WERE NOT AVAILABLE FOR SUBMISSION. GN ID LOT # 2410252203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING. NO NCMRS WERE WRITTEN AGAINST THIS LOT. NCMRS WERE REVIEWED FOR THE LAST 13 MONTHS (23DEC2016-23JAN2018); NO NCMRS WERE WRITTEN AGAINST THE GN ID CARD. WITHOUT STRAIN, LAB REPORTS AND RAW DATA, ITS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MIS-IDENTIFICATION. THE INVESTIGATION CONCLUDED THERE IS NO INVESTIGATIONAL EVIDENCE THAT THE VITEK 2 GN ID CARD PERFORMED OUTSIDE OF SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF PSEUDOMONAS AS AEROMONAS IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER REPORTED THAT THE TEST WAS REPEATED AND THE SAME RESULT WAS OBTAINED. THE CUSTOMER STATED THE MASS SPECTROMETRY RESULT MATCHED THE EXPECTED ORGANISM IDENTIFICATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE CUSTOMER. 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
    863021 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX, INC 2410252203

    Patients

    Seq Age Sex Outcome Treatment
    1