BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS

    MDR report key: 8612119 · Received May 15, 2019

    Report

    Report Number
    9615754-2019-00037
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Report Date
    October 7, 2019
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED IN RESPONSE TO A CUSTOMER COMPLAINT FOR A MISIDENTIFICATION OF A PATIENT ISOLATE AS STREPTOCOCCUS PYOGENES (S. PYOGENES) IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT, KNOWLEDGE BASE V3.0 (REFERENCE 410895). THE STRAIN WAS SUBMITTED FOR INVESTIGATIONAL TESTING. FIVE (5) SPOT PREPARATIONS WERE TESTED INTERNALLY BY BIOMÉRIEUX USING THE VITEK® MS WITH KNOWLEDGE BASE VERSION 3.0. 3 SPOTS: LOW DISCRIMINATION STREPTOCOCCUS CANIS / S. DYSGALACTIAE SSP DYSGALACTIAE / S. DYSGALACTIAE SSP EQUISIMILIS. 2 SPOTS: NO IDENTIFICATION. THE ISOLATE WAS ALSO SENT TO A REFERENCE LABORATORY FOR 16S RRNA GENE SEQUENCING AND WAS IDENTIFIED AS STREPTOCOCCUS CANIS. SINCE THE IDENTIFICATION OF STREPTOCOCCUS CANIS WAS NOT OBTAINED AS A SINGLE CHOICE IDENTIFICATION FOR ANY OF THE SPOTS PREPARED DURING INVESTIGATIONAL TESTING, THE STRAIN MAY BE AN ATYPICAL S. CANIS STRAIN. THE CUSTOMER'S MISIDENTIFICATION OF S. CANIS AS S. PYROGENES WAS NOT REPRODUCED INTERNALLY AND THE REASON FOR THE MISIDENTIFICATION IS UNKNOWN. REVIEW OF THE CUSTOMER'S DATA IDENTIFIED THAT THE VITEK® MS SYSTEM WAS OPERATIONAL DURING THE TESTS AND THE CUSTOMER'S SPOT PREPARATION QUALITY IS ACCEPTABLE. SINCE JANUARY 2016, NO OTHER COMPLAINTS HAVE BEEN RECORDED FOR A MISIDENTIFICATION OF STREPTOCOCCUS CANIS.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION OF A PATIENT ISOLATE AS STREPTOCOCCUS PYOGENES (S. PYOGENES) IN ASSOCIATION WITH THE VITEK MSINSTRUMENT, KNOWLEDGE BASE V3.0 (REFERENCE 410895). THE ORGANISM WAS SUBCULTURED AND REPEATED AGAIN ON THE VITEK MS AND OBTAINED THE SAME S. PYOGENES RESULT. THE CUSTOMER ALSO PERFORMED A BBL DRY SLIDE PYR TEST WHICH YIELDED A NEGATIVE RESULT. IN ADDITION THE CUSTOMER ALSO PERFORMED PROLEX LATEX AGGLUTINATION TESTS RESULTS ARE LISTED BELOW: BBL DRY SLIDE PYR =NEGATIVE. LATEX AGGLUTINATION TEST GROUP A: NEGATIVE. THE RESULTS FROM THE BBL DRY SLIDE PYR TEST AND THE LATEX AGGLUTINATION TEST SUPPORTS THAT THE ISOLATE IS NOT S. PYOGENES (GROUP A STREPTOCOCCUS). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407361 VITEK® MS VITEK® MS PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1