BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11792545 · Received May 7, 2021

    Report

    Report Number
    9615754-2021-00147
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATOR REVIEWED THE COMPLAINTS DATABASE TO FIND SIMILAR ISSUES THAT WERE PREVIOUSLY REPORTED. A CHANGE REQUEST ((B)(4)) WAS PREVIOUSLY SUBMITTED AGAINST THE KNOWLEDGE BASE TO IMPROVE HANDLING OF POOR QUALITY SPECTRA. THERE ARE NO CAPAS NOR NON-CONFORMITIES AGAINST VITEK MS SIMILAR TO THE CUSTOMER 'S COMPLAINT. FINE TUNING: ACCORDING TO VILINK ALERT TOOL CRITERIA, NO FINE TUNING WAS NEEDED DURING CUSTOMER¿S TESTS. SPOT PREPARATION: THE CALIBRATOR AND SAMPLE SPOT PREPARATION WERE NOT OPTIMAL. THE ¿ALL PEAKS¿ VALUES ARE HETEROGENEOUS. KNOWLEDGE BASE NO REFERENCE METHOD WAS USED TO CONFIRM THE ORGANISM IDENTIFICATION, SO THE 'EXPECTED IDENTIFICATION' REMAINS UNKNOWN. DATA ANALYSIS: THE SAMPLE ¿ALL PEAKS¿ VALUES ARE HETEROGENEOUS, VARYING BETWEEN 47 AND 86. IN ADDITION, THE NUMBER OF PEAKS DETECTED FOR SOME IDENTIFICATIONS FILES ARE LOW. FIVE (5) OUT OF THE SIX (6) IDENTIFICATIONS WERE OBTAINED WITH A LOW SCORE (BETWEEN -0.37 AND -0.19), WHICH ARE NEAR THE LIMIT VALUE OF -0.4 FOR GIVING A 'NO IDENTIFICATION' RESULT. FOUR (4) OUT OF THE SIX (6) TESTS GAVE AN IDENTIFICATION TO S. CANIS, SUGGESTING THAT THIS MAY BE THE CORRECT ORGANISM IDENTIFICATION. ROOT CAUSE: NON-OPTIMAL SPOT PREPARATION (AS SHOWN BY SPECTRA HAVING HETEROGENEOUS PEAKS). AS THE EXPECTED IDENTIFICATION REMAINS UNKNOWN, IT IS POSSIBLE THE ORGANISM IS A SPECIES NOT CURRENTLY PART OF KNOWLEDGE BASE (KB) V3.2. CORRECTIVE AND PREVENTATIVE ACTION: LOCAL CUSTOMER SERVICE REQUESTED THE CUSTOMER PERFORM A NEW FINE TUNING AS WELL AS PROVIDED ADDITIONAL TRAINING MATERIALS TO THE CUSTOMER TO HELP IMPROVE THE SPOT PREPARATION TECHNIQUE. SERVICE ALSO PROVIDED INFORMATION REGARDING VITEK® PICKME¿ (REF (B)(4)). SERVICE FURTHER REQUESTED THAT SHOULD THIS TYPE OF MISIDENTIFICATION RECUR, THE SITE CONFIRM THE ORGANISM IDENTIFICATION USING A REFERENCE METHOD.

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF STREPTOCOCCUS CANIS AS BRUCELLA SPP AND AS A LOW-DISCRIMINATION IDENTIFICATION THAT DID NOT INCLUDE STREPTOCOCCUS CANIS, IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (REF 410895, SERIAL (B)(4)). THE ISOLATE WAS DETERMINED TO BE A BETA-HEMOLYSING STREPTOCOCCUS. THE CUSTOMER REPORTED OBTAINING AN IDENTIFICATION OF BRUCELLA SPP. INITIALLY. REPEAT ANALYSIS OBTAINED "NO IDENTIFICATION". FURTHER TESTING OBTAINED A LOW-DISCRIMINATION IDENTIFICATION OF STREPTOCOCCUS SALIVARIUS SSP THERMOPHILUS / STREPTOCOCCUS VESTIBULARIS / STREPTOCOCCUS SALIVARIUS SSP SALIVARIUS. A FINAL TEST OBTAINED A SINGLE-CHOICE IDENTIFICATION TO STREPTOCOCCUS CANIS. VITEK MS TEST 1: BRUCELLA SPP VITEK MS TEST 2: NO IDENTIFICATION VITEK MS TEST 3: LOW DISCRIMINATION S. SALIVARIUS SSP THERMOPHILUS / S. VESTIBULARIS / S. SALIVARIUS SSP SALIVARIUS VITEK MS TEST 4: STREPTOCOCCUS CANIS CATALASE: NEGATIVE COAGULASE: NEGATIVE IT WAS REPORTED THAT THERE WAS A DELAY >24 HOURS IN REPORTING RESULTS; HOWEVER THERE IS NO INDICATION OR REPORT THAT THE MISIDENTIFICATION OR THE DELAY LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686991 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1