BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT - 410895

    MDR report key: 12720276 · Received October 29, 2021

    Report

    Report Number
    9615754-2021-00277
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN SINGAPORE REPORTED AN INCORRECT ORGANISM IDENTIFICATION FOR A GRAM POSITIVE COCCI IN ASSOCIATION WITH THE VITEK® MS. INVESTIGATION FINE TUNING: ACCORDING TO THE VILINK ALERT TOOL CRITERIA, FINE TUNING WAS GOOD DURING THE TESTS MADE ON (B)(6) 2021. A NEW FINE TUNING WAS PERFORMED ON (B)(6) 2021. FINE TUNING INDICATORS ACCEPTANCE CRITERIA COULD BE AFFECTED BY THE NON-OPTIMAL QUALITY OF THE CALIBRATOR SPOT PREPARATION. IN THESE CONDITIONS, IT MIGHT NOT REFLECT THE REAL STATUS OF THE SYSTEM. GOOD FINE TUNING AND GOOD CALIBRATOR SPOT PREPARATION ARE A PREREQUISITE FOR MONITORING THE SYSTEM WITH VILINK ALERT TOOL. SPOT PREPARATION QUALITY: THE CUSTOMER¿S SPOT PREPARATION QUALITY IS NOT OPTIMAL. THE SAMPLE ¿ALL PEAKS¿ VALUES ARE QUITE HETEROGENEOUS. KNOWLEDGE BASE (KB) REVIEW: THE EXPECTED IDENTIFICATION IS ENTEROCOCCUS FAECALIS, WHICH IS INCLUDED IN THE VITEK® MS KNOWLEDGE BASE V 3.2. SAMPLE DATA ANALYSIS: ACCORDING TO DATA PROVIDED, THE MISIDENTIFICATION RESULT WAS OBTAINED FROM SPECTRA HAVING A LOW NUMBER OF PEAKS (47) WHICH IS NEAR THE ACCEPTABLE LIMIT FOR GIVING AN ¿IDENTIFICATION¿ RESULT OR A ¿NO IDENTIFICATION¿ RESULT (30). MOREOVER, MISIDENTIFICATION WAS OBTAINED WITH A LOW IDENTIFICATION SCORE (-0;37) WHICH IS ALSO NEAR THE ACCEPTABLE LIMIT FOR GIVING AN ¿IDENTIFICATION¿ RESULT OR A ¿NO IDENTIFICATION¿ RESULT (-0.4). THE TESTS MADE AFTER A NEW FINE TUNING RESULTED IN THE EXPECTED IDENTIFICATION AS ENTEROCOCCUS FAECALIS. DURING THE ANALYSIS OF THE INSTRUMENT STATUS, THE INVESTIGATOR OBSERVED THAT THE ¿ALL PEAKS¿ VALUES AND ¿GOOD PEAKS¿ VALUES RECENTLY DECREASED RAPIDLY COMPARED TO THE VALUE OBSERVED DURING THE FINE TUNING. THIS CAN OCCUR WHEN THE SLIDE PREPARED FOR THE FINE TUNING PURPOSE HAS BEEN DONE BY ONE PERSON AND SOMETHING DIFFERENT HAPPENS DURING THE QUALITY PREPARATION IN ROUTINE USE (I.E. CULTURE, SPOT, DIFFERENT OPERATOR, OPERATOR SKILLS, ¿). ALL PEAKS VALUES ARE HETEROGENEOUS (VARIES BETWEEN 47 TO 76), INDICATING NON-OPTIMAL SPOT PREPARATION LINKED WITH A DRIFT IN THE FINE TUNING STATE. CONCLUSION: PER THE INVESTIGATION INFORMATION, THIS ISSUE OCCURRED DUE TO NON-OPTIMAL SPOT PREPARATION. LOCAL CUSTOMER SERVICE PROVIDED THE CUSTOMER WITH ADDITIONAL TRAINING MATERIALS TO HELP IMPROVE THEIR SPOT PREPARATION TECHNIQUE. CUSTOMER SERVICE ALSO PROVIDED INFORMATION REGARDING VITEK® PICKME¿ (REF 423551/ 423546) TO HELP WITH SAMPLE SPOT PREPARATION. THE FINE TUNING STATUS ALSO HAS TO BE MONITORED PERIODICALLY (REFERRED CUSTOMER TO THE SERVICE MANUAL OR MAR 3262).

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) REPORTED A NEW COMPLAINT REGARDING A WRONG VITEK® MS IDENTIFICATION OF GRAM POSITIVE COCCI. VITEK® MS VERSION : VMS 3.0 (KB3.2); SAMPLE SOURCE = URINE CULTURE; ACCESSION : M211174029. CULTURE EXAMINATION UPON FULL 24 HOURS INCUBATION : PURE GROWTH OF GRAM POSITIVE COCCI ON TSAB CULTURE PLATE. COLONY MORPHOLOGY: GOOD GROWTH AT 24 HOURS INCUBATION, SMALL NON-HAEMOLYTIC, WHITISH COLONIES. GRAM MORPHOLOGY: GRAM POSITIVE COCCI. USER PERFORMED ID USING VITEK® MS FROM TSAB CULTURE PLATES, AND THE RESULTS WERE: TSAB ON (B)(6) 2021 (24 HOURS FRESH CULTURE): LACTOCOCCUS LACTIS 99.9%. SUBCULTURE TSAB ON (B)(6) 2021 (24 HOURS FRESH CULTURE): SINGLE CHOICE OF E. FAECALIS (99.9%). USER PERFORMED API® 20 STREP TO CONFIRM ID. THE RESULT IS E. FAECALIS. FINAL REPORTING BY USER AS E. FAECALIS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617251 VITEK MS INSTRUMENT - 410895 VITEK MS INSTRUMENT QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown