BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM NEGATIVE TEST KIT

    MDR report key: 7117451 · Received December 14, 2017

    Report

    Report Number
    1950204-2017-00451
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Report Date
    March 19, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED INCONSISTENT IDENTIFICATION OF A CRONOBACTER SAKAZAKII STRAIN IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER SUBMITTED THE ISOLATES FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE TWO (2) ISOLATES WERE SUBBED, AND TESTING INCLUDED BOTH THE CUSTOMER LOT AND A RANDOM LOT OF GN CARDS, RUN IN DUPLICATE. API 20 E, VITEK MS, AND 16S SEQUENCING WERE ALSO PERFORMED. ISOLATE 911498: AN UNIDENTIFIED ORGANISM CALL WAS OBTAINED ON ONE OF THE CARDS FROM THE CUSTOMER LOT. AN ACCEPTABLE ID OF E. VULNERIS WAS OBTAINED ON THE OTHER CUSTOMER CARD AND THE TWO CARDS OF THE RANDOM LOT. API 20 E GAVE A RESULT OF "IDENTIFICATION NOT VALID". VITEK MS GAVE A NO ID RESULT. 16S SEQUENCING IDENTIFIED THE ORGANISM AS SHIGELLA SONNEI, WITH A 99% IDENTITY MATCH. ISOLATE 911499: AN ACCEPTABLE ID OF LECLERCIA ADECARBOXYLATA WAS OBTAINED ON ONE CUSTOMER CARD AND ONE RANDOM CARD. A GOOD ID OF E. VULNERIS WAS OBTAINED ON THE OTHER CUSTOMER AND RANDOM LOT CARDS. API 20 E GAVE A RESULT OF "IDENTIFICATION NOT VALID". VITEK MS GAVE A SLASHLINE IDENTIFICATION OF VIBRIO CHOLERA/ RAOULTELLA TERRIGENA. 16S SEQUENCING IDENTIFIED THE ORGANISM AS SHIGELLA SONNEI, WITH A 99% IDENTITY MATCH. A COMPARISON OF CARD REACTION RESULTS FOR E. VULNERIS AGAINST EXPECTED REACTION RESULTS FOR S. SONNEI RESULTED IN SEVEN ATYPICAL POSITIVE REACTIONS (DCEL, GGT, BGLU, BXYL, MNT, AGLU, ELLM) AND FIVE ATYPICAL NEGATIVE REACTIONS (PROA, GLYA, ODC, CMT, BGUR) WHICH LED TO THE INCORRECT CALL. A COMPARISON OF CARD REACTION RESULTS FOR L. ADECARBOXYLATA AGAINST EXPECTED REACTION RESULTS FOR S. SONNEI RESULTED IN SEVEN ATYPICAL POSITIVE REACTIONS (DCEL, GGT, BGLU, BXYL, MNT, AGLU, ELLM) AND TWO ATYPICAL NEGATIVE REACTIONS (ODC, BGUR) WHICH LED TO THE INCORRECT CALL. A COMPARISON OF CARD REACTION RESULTS FOR C. SAKAZAKII GROUP AGAINST EXPECTED REACTION RESULTS FOR S. SONNEI RESULTED IN TEN ATYPICAL POSITIVE RESULTS (PYRA, DCEL, GGT, BGLU, BXYL, LIP, URE, MNT, AGLU, ELLM) WHICH LED TO THE INCORRECT CALL. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON- RECOMMENDED MEDIA, USER SET UP ERRORS, OR AN ATYPICAL STRAIN. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. THE INVESTIGATION CONCLUDED THE SUBMITTED ISOLATES HAVE AN ATYPICAL BIOCHEMICAL PROFILE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT INCONSISTENT ORGANISM IDENTIFICATION OF A SUSPECTED CRONOBACTER SAKAZAKII STRAIN IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE INITIAL GN ID TEST IDENTIFIED THE STRAIN AS CRONOBACTER SAKAZAKII. UPON REPEAT TESTING (TWICE), THE RESULTS WERE LECLERCIA ADECARBOXYLATA AND ESCHERICHIA VULNERIS. AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER PERFORMED CONFIRMATORY TESTING VIA ALTERNATE METHOD (16S RNA SEQUENCING). THE OBSERVED RESULT WAS SHIGELLA SONNEI. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895958 VITEK® 2 GRAM NEGATIVE TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX INC. 2410294103 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1