BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 7138346 · Received December 21, 2017

    Report

    Report Number
    1950204-2017-00468
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    March 14, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQM
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION OF CHROMOBACTERIUM VIOLACEUM AS VIBRIO MIMICUS IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED SETTING UP THE ISOLATE FROM BLOOD AGAR AND MAC CONKEY AGAR WHICH GAVE THE MISIDENTIFCATION OF V. MIMICUS. THE CUSTOMER ALSO SET UP THE ISOLATE FROM LYSIN AND TSI AGAR (WHICH ARE NOT RECOMMENDED MEDIA) IN THE GN CARD WHICH GAVE THE IDENTIFICATION OF C. VIOLACEUM. NO OTHER SET UP INFORMATION WAS PROVIDED. THREE LAB REPORTS WERE SUBMITTED SHOWING EXCELLENT IDENTIFICATIONS OF V. MIMICUS (FROM BLOOD AGAR, REPEAT BLOOD AGAR AND MAC). ALL THREE LAB REPORTS SHOWED ONE ATYPICAL POSITIVE REACTION (GGAA) FOR AN IDENTIFICATION OF C. VIOLACEUM. TWO LAB REPORTS WERE ALSO SUBMITTED SHOWING EXCELLENT IDENTIFICATIONS OF C. VIOLACEUM (FROM LYSIN AND TSI AGAR). IT IS NOT CLEAR IF THE TRUE IDENTIFICATION OF THIS ISOLATE IS C. VIOLACEUM. THIS SPECIES TYPICALLY HAS PURPLE COLONIES WHICH THE CUSTOMER DID NOT MENTION OF THIS ISOLATE. IT'S POSSIBLE THE ISOLATE COULD BE ANOTHER SPECIES AND/OR ONE UNCLAIMED BY THE GN CARD. ATYPICAL 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 MISIDENTIFICATION. THE VITEK 2 GN LOT # 2410263203 MET FINAL QC RELEASE CRITERIA AND PASSED INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF CHROMOBACTERIUM VIOLACEUM AS VIBRIO MIMICUS, FOR A PATIENT SPUTUM SAMPLE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER REPORTED THAT THEY RECEIVED INCONSISTENT IDENTIFICATION RESULTS WITH THE GN CARD WHEN USING DIFFERENT CULTURE MEDIUMS. THE ORGANISM WAS TWICE IDENTIFIED AS VIBRIO MIMICUS, AND IDENTIFIED AS CHOMOBACTERIM VIOLACEUM THREE TIMES. THE CUSTOMER REPORTED CHOMOBACTERIM VIOLACEUM TO THE PHYSICIAN. 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
    918689 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX, INC 2410263203

    Patients

    Seq Age Sex Outcome Treatment
    1