BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 7799196 · Received August 20, 2018

    Report

    Report Number
    1950204-2018-00293
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO AN INDUSTRIAL CUSTOMER REPORT OF A MISIDENTIFICATION OF SALMONELLA SPP AS SERRATIA FONTICOLA WHEN TESTING A BIOSAFETY LEVEL 3 PRODUCTION STRAIN, FROM FERMENTOR CULTURE, IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE ISOLATE WAS NOT SUBMITTED FOR THE INVESTIGATION. THE ISOLATE WAS TESTED BY THE CUSTOMER FROM TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD AND INCUBATED AT 36.5°C. THE MCFARLAND OF THE SUSPENSION WAS 0.59. THE SUSPENSION WAS LOADED WITHIN FIVE (5) MINUTES AFTER PREPARATION. THE STRAIN IDENTIFICATION WAS CONFIRMED BY (B)(6). ONE LAB REPORT WAS RECEIVED. THE LAB REPORT SUBMITTED HAD AN EXCELLENT IDENTIFICATION OF SERRATIA FONTICOLA WITH ONE ATYPICAL NEGATIVE REACTION (H2S) FOR AN IDENTIFICATION OF SALMONELLA SPP ACCORDING THE GN KNOWLEDGE BASE. THE RAW DATA WAS SUBMITTED. A REVIEW OF THE RAW DATA FOR REACTIONS THAT GENERALLY DIFFERENTIATE SALMONELLA FROM OTHER SPECIES WAS PERFORMED. H2S, DMAL AND LIPASE REACTIONS ARE EXPECTED POSITIVE, BUT THE GROWTH CURVES FOR THIS ISOLATE WERE VERY NEGATIVE. PROA AND TYRA ARE ALSO EXPECTED POSITIVE BUT THE GROWTH CURVES DEMONSTRATED A SLOW AND DELAYED POSITIVE GROWTH RESULT. THE ODC WELL IS ALSO EXPECTED POSITIVE BUT DEMONSTRATED AN ATYPICAL GROWTH PATTERN IN THE WELL. IT APPEARS THAT THIS STRAIN EXHIBITED ATYPICAL GROWTH IN THE GN CARD WHEN COMPARED TO OTHER SALMONELLA SPECIES IN THE GN KNOWLEDGE BASE. WITHOUT THE STRAIN IT IS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. ATYPICAL NEGATIVE REACTIONS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. THE VITEK 2 GN TEST KIT, LOT 2410326203, MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO AN INDUSTRIAL CUSTOMER IN FRANCE REPORTING A MISIDENTIFICATION OF SALMONELLA SPP AS SERRATIA FONTICOLA WHEN TESTING A BIOSAFETY LEVEL 3 PRODUCTION STRAIN, FROM FERMENTOR CULTURE, IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. NEW INVESTIGATION INFORMATION, FURTHER TESTING WAS REQUESTED: COMPARISON OF THE THREE (3) H2S NEGATIVE SALMONELLA STRAINS WITH THE SALMONELLA STRAIN THAT MISIDENTIFIED AS SERRATIA FONTICOLA WAS REQUESTED. THE SALMONELLA SPECIES ISOLATE 1554632CI MFA-1 GAVE A MISIDENTIFICATION OF SERRATIA FONTICOLA. THIS ISOLATE WAS COMPARED WITH THREE (3) H2S NEGATIVE ISOLATES THAT GIVE THE CORRECT IDENTIFICATION OF SALMONELLA SPECIES. THE RAW DATA AND THREE (3) LAB REPORTS WERE SUBMITTED WITH NEW INFORMATION REGARDING THREE (3) H2S NEGATIVE ISOLATES. WHEN COMPARING THE RAW DATA GRAPHS, ALL FOUR (4) ISOLATES ARE DEMONSTRATING ATYPICAL NEGATIVE H2S, GGT, AND ODC FOR A CALL OF SALMONELLA SPECIES WITH THE GN KNOWLEDGE BASE. IN ADDITION, ISOLATE 1554632CI MFA-1 , TYPH1554453FCIJDS-1, AND - TYPHI1542590JDS-1 ALSO HAVE AN ATYPICAL POSITIVE ELLM REACTION. AFTER REVIEWING ALL THE WELLS FOR COMPARISON, ALL FOUR (4) ISOLATES HAVE SIMILAR RAW DATA GRAPHS. THE DIFFERENCE IS THAT THE HOUR OF CALL FOR ISOLATE 1554632CI MFA-1 HAD AN HOUR OF ANALYSIS OF FOUR (4) HOURS . TYPH1554453FCIJDS-1 , TYPHI1542590JDS-1, AND 1540583TYPHIHMD30031-1 HAVE AN HOUR OF ANALYSIS OF 10.25 HOURS. BECAUSE 1554632CI MFA-1 HAD AN HOUR OF ANALYSIS OF FOUR (4) HOURS, THE POSITIVE REACTION FOR PROA, DMAL, TYRA, SUCT, AND LLATA WERE NOT INCLUDED IN THE KINETIC ANALYSIS. THESE WELLS REQUIRE A LONGER HOUR OF ANALYSIS. WITHOUT THE STRAIN IT IS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. ATYPICAL NEGATIVE REACTIONS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. VITEK 2 GN ID TEST KIT, LOT # 2410326203, MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    AN INDUSTRIAL CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF SALMONELLA SPP AS SERRATIA FONTICOLA WHEN TESTING A BIOSAFETY LEVEL 3 PRODUCTION STRAIN, FROM FERMENTOR CULTURE, IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER WAS EXPECTING TO HAVE AN IDENTIFICATION FOR SALMONELLA SPP, BUT OBTAINED AN EXCELLENT IDENTIFICATION OF SERRATIA FONTICOLA (99%). THE CUSTOMER STATED THE THREE VITEK TESTS THAT SHOULD BE POSITIVE FOR SALMONELLA SPP (DMAL, PROA AND TYRA) WERE NEGATIVE. THE CUSTOMER IDENTIFIED SALMONELLA SPP BY THE MALDI-TOF METHOD. THE CULTURE MEDIUM USED IS NOT KNOWN. THERE IS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO AN INDUSTRIAL PRODUCTION STRAIN. THE STRAIN IS NOT AVAILABLE FOR EVALUATION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639831 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX, INC. 2410326203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1