BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    MDR report key: 5997438 · Received October 4, 2016

    Report

    Report Number
    1950204-2016-00140
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Report Date
    September 6, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF (B)(6) SURVEY ORGANISM ENTEROCOCCUS GALLINARUM AS ENTEROCOCCUS CASSELIFLAVUS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. ON A (B)(6) SURVEY ((B)(6)), 74% OF BIOLOGISTS REPORTED ENTEROCOCCUS GALLINARUM, ON GP CARD (VITEK® 2 SOFTWARE VERSION V7.01): MISIDENTIFICATION AS ENTEROCOCCUS CASSELIFLAVUS. THE ORGANISM WAS SUBCULTURED ON CBA MEDIA AND COH MEDIA, TESTED ON 16S SEQUENCING, VITEK® MS, AND ON FOUR (4) DIFFERENT LOTS OF VITEK® 2 GP CARDS. THE VITEK® 2 GP CARDS TESTED IN-HOUSE, GAVE ON 5/8 TESTS, A LOW DISCRIMINATION BETWEEN ENTEROCOCCUS GALLINARUM AND ENTEROCOCCUS CASSELIFLAVUS , WITH ONE (1) TEST AGAINST CDEX FOR E. GALLINARUM. FOR 3/8 TESTS (CL2 AND CL3), VITEK® 2 GP CARDS GAVE EXCELLENT IDENTIFICATION TO ENTEROCOCCUS GALLINARUM (98%). THE CUSTOMER'S RESULT WAS NOT DUPLICATED: MISIDENTIFICATION TO ENTEROCOCCUS CASSELIFLAVUS ON VITEK® 2, BUT THE LOW DISCRIMINATION BETWEEN THESE 2 SPECIES, E. GALLINARUM AND E. CASSELIFLAVUS, WAS REPRODUCED. REMARK: THE CDEX TEST NEGATIVE IS ATYPICAL ON VITEK® 2 AND CONFIRMED ON RAPID ID32STREP STRIP. THE NON-YELLOW PIGMENTATION OF THE COLONY IS IN FAVOR OF E. GALLINARUM (COMPLEMENTARY TEST RECOMMENDED); ATYPICAL STRAIN. PER INTERNAL TESTING, THE IDENTIFICATION TO THE SPECIES E. GALLINARUM WAS WELL CONFIRMED ON SEQUENCING AND ON VITEK® MS.

    Description of Event or Problem · 1

    A CUSTOMER IN IRELAND CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF NEQAS SURVEY ORGANISM ENTEROCOCCUS GALLINARUM AS ENTEROCOCCUS CASSELIFLAVUS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. REPEAT TEST OBTAINED THE SAME RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE NEQAS SURVEY SAMPLE. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648543 VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT VITEK® 2 GP ID CARD LQL BIOMERIEUX, INC 242394310

    Patients

    Seq Age Sex Outcome Treatment
    1