BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11140533 · Received January 8, 2021

    Report

    Report Number
    9615754-2021-00005
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    January 8, 2021
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS PERFORMED BY ANALYZING THE CUSTOMER¿S PROVIDED DATA. FINE TUNING: THE CUSTOMER DID NOT PROVIDE THE FINE TUNING REPORT PERFORMED BEFORE THEIR REPORTED ISSUE, THUS THE INVESTIGATOR COULD NOT VERIFY WHETHER THAT STATUS MET THE REQUIRED SPECIFICATIONS. SPOT PREPARATION QUALITY: THE SAMPLE ¿ALL PEAKS¿ VALUES WERE HOMOGENEOUS FOR MOST OF THE TESTS (EXCEPTING ONE WHICH DISPLAYED NO PEAKS). SAMPLE SPECTRA WITH SIMILAR NUMBERS OF ¿ALL PEAKS¿ GAVE ¿NO IDENTIFICATION¿ RESULTS. THE CALIBRATOR SPOT PREPARATION QUALITY WAS NOT OPTIMAL. HOWEVER, BASED ON THIS ANALYSIS, IT SEEMS THAT SAMPLE PREPARATION IS NOT THE CAUSE OF THE ISSUE. SAMPLE DATA ANALYSIS: REPROCESSING OF THE CUSTOMER DATA WITH VITEK MS KNOWLEDGE BASE (KB) (B)(4) GAVE NINE ¿NO IDENTIFICATION¿ RESULTS AND ONE SINGLE CHOICE TO PSEUDOMONAS PUTIDA. THE P. PUTIDA RESULT WAS OBTAINED WITH A LOW IDENTIFICATION SCORE (-0.38) WHICH IS NEAR THE ACCEPTABLE LIMIT FOR GIVING AN ¿IDENTIFICATION¿ OR A ¿NO IDENTIFICATION¿ RESULT (-0.4). REPROCESSING OF THE CUSTOMER DATA WITH VITEK MS KB (B)(4) GAVE ¿NO IDENTIFICATION¿ FOR ALL TESTS. REPROCESSING THE DATA USING THE VITEK MS KB VERSION CURRENTLY UNDER DEVELOPMENT GAVE A RESULT OF P. OTIDIS FOR 8 OUT OF THE 10 TESTS PERFORMED; THE TWO OTHERS PROVIDING NO IDENTIFICATION RESULTS. BASED ON THESE RESULTS, THE MOST PROBABLE IDENTIFICATION IS P. OTIDIS. THIS SUPPORTED BY THE FOLLOWING ELEMENTS : THERE WERE A HIGH NUMBER OF ¿NO IDENTIFICATION¿ RESULTS. THE FOLLOWING SYSTEM LIMITATION IS MENTIONED IN THE VITEK MS KNOWLEDGE BASE USER MANUAL FOR KB (B)(4): ¿TESTING OF SPECIES NOT FOUND IN THE DATABASE MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION.¿ P. OTIDIS IS NOT PRESENT IN VITEK MS KB (B)(4) AND IS NOT PRESENT IN VITEK 2 VERSION (B)(4). ROOT CAUSE ANALYSIS: SPECIES NOT PRESENT IN VITEK MS KB (B)(4). FOLLOWING THE INVESTIGATION, IT IS RECOMMENDED THAT ORGANISM IDENTIFICATION BE CONFIRMED VIA A REFERENCE METHOD, SUCH AS SEQUENCING. IT WAS RECOMMENDED THAT LOCAL CUSTOMER SERVICE CHECK SAMPLE PREPARATION WITH THE CUSTOMER AND PROVIDE CUSTOMER TRAINING MATERIALS TO IMPROVE THEIR SPOT PREPARATION TECHNIQUE, AS WELL AS REVIEWING WITH THEM MANDATORY CRITERIA FOR FINE TUNING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION WHEN USING THE VITEK® MS INSTRUMENT (REF. 410895, S/N (B)(4)). THE SAME PATIENT HAD TWO RECTAL SAMPLES TAKEN. THE FIRST ISOLATE NUMBER WAS M54272. THIS RECTAL SWAB WAS TAKEN ON THE (B)(6) 2020. THE SECOND ISOLATE NUMBER WAS M55633. THIS RECTAL SWAB WAS TAKEN ON THE (B)(6) 2020. THE BACTERIAL STRAINS ISOLATED FROM THESE SWABS WERE OXIDASE POSITIVE ON CPE MEDIUM. CUSTOMER SERVICE REVIEWED THE CUSTOMER¿S RAW DATA AND CONFIRMED THAT THE FOLLOWING RESULTS WERE OBTAINED FOR EACH ISOLATE: FIRST ISOLATE M54272 ON (B)(6) 2020 : FOUR ¿NO IDENTIFICATION¿ RESULTS. ON (B)(6) 2020 : TWO ¿NO IDENTIFICATION¿ RESULTS. SECOND ISOLATE M55633 ON (B)(6) 2020 : TWO ¿NO IDENTIFICATION¿ RESULTS. ON (B)(6) 2020 : ONE ¿NO IDENTIFICATION¿ RESULT AND ONE SINGLE CHOICE TO PSEUDOMONAS PUTIDA. THE CLIENT USED AN ALTERNATIVE METHOD, VITEK 2 GN CARD, WHICH OBTAINED AN IDENTIFICATION OF PSEUDOMONAS AERUGINOSA. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36238 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1