BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM NEGATIVE ID TEST KIT

    MDR report key: 7822409 · Received August 28, 2018

    Report

    Report Number
    1950204-2018-00305
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Report Date
    October 22, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA SONNEI FOR A URINE ISOLATE IN ASSOCIATION WITH THE VITEK® 2 GRAM NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. AN INVESTIGATION WAS PERFORMED. THE THREE SUBMITTED SLANTS WERE SUBCULTURED TO TSAB AND MACCONKEY AGAR. FOR ISOLATE B5301332 THE SUBCULTURE DEMONSTRATED ONE COLONY TYPE AND LACTOSE FERMENTATION. FOR ISOLATES B6151092 #1 AND B6151092 #2, THE SUBCULTURES EACH DEMONSTRATED TWO DISTINCT COLONY MORPHOLOGIES AND WERE ISOLATED FOR TESTING. THE TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH GN CARDS FROM THE CUSTOMER'S TWO LOTS (2410445403 AND 2410593203) AND A RANDOM LOT (2410599403) AS WELL AS VITEK MS. 911722 (B5301332): GN CARDS TESTED RESULTED IN VERY GOOD ID: ESCHERICHIA COLI X3 911723 (B6151092#1 MUCOID) LF: GN CARDS TESTED RESULTED IN EXCELLENT AND VERY GOOD ID: ESCHERICHIA COLI X3 911724 (B6151092#1 FLAT GRAY) LF: GN CARDS TESTED RESULTED IN EXCELLENT ID: ESCHERICHIA COLI X3 911725 (B6151092 #2 MUCOID) NLF: GN CARDS TESTED RESULTED IN EXCELLENT ID: ESCHERICHIA COLI X3 911726 (B6151092 #2 FLAT GRAY) NLF: GN CARDS TESTED RESULTED IN EXCELLENT ID: ESCHERICHIA COLI X3 VITEK MS RESULTED IN IDENTIFICATIONS OF E. COLI WITH A 99.9 % CONFIDENCE VALUE FOR ALL FIVE ISOLATES. IN CONCLUSION, THE VITEK 2 GN CARDS ARE PERFORMING AS EXPECTED. NOTE: ANY IDENTIFICATION OF SHIGELLA SHOULD BE CONFIRMED WITH ANOTHER METHOD SUCH AS SEROLOGY. THE GN LAB REPORT PRINTS THE MESSAGE "CONFIRM BY SEROLOGICAL TESTS" FOR ANY IDENTIFICATION OF SHIGELLA. A REVIEW OF THE CUSTOMERS SHIGELLA SONNEI RESULTS SHOWED THREE ATYPICAL NEGATIVE REACTIONS (DSOR, LDC, PHOS) FOR AN IDENTIFICATION OF E. COLI ACCORDING TO THE GN KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL REACTIONS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA OR OTHER USER SET UP ERROR.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA SONNEI FOR A URINE ISOLATE IN ASSOCIATION WITH THE VITEK® 2 GRAM NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE ISOLATE WAS A LACTOSE FERMENTER, INDICATING AN IDENTIFICATION OF SHIGELLA WAS NOT POSSIBLE. REPEAT TEST VIA DIFFERENT GN ID LOT NUMBER GAVE AN ORGANISM IDENTIFICATION OF ESCHERICHIA COLI. NO INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING ANY REFERENCE OR ALTERNATE METHOD TESTING PERFORMED. THE CUSTOMER STATED THEY "BENCH ID'D" THE ORGANISM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664912 VITEK® 2 GRAM NEGATIVE ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX INC. 2410445403 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1