BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS

    MDR report key: 11682031 · Received April 16, 2021

    Report

    Report Number
    9615754-2021-00072
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO THIS COMPLAINT OF A MISIDENTIFICATION OF PAENIBACILLUS ODORIFER. THE RAW DATA GENERATED DURING TESTING WAS ANALYZED FOR THIS INVESTIGATION. COMPLAINT TRENDING: COMPLAINT TRENDING DID NOT IDENTIFY THIS ISSUE AS A TREND FOR THE VITEK MS. FINE TUNING: ACCORDING TO VILINK ALERT TOOL CRITERIA, NO FINE TUNING WAS NEEDED DURING TESTING. SPOT PREPARATION: THE SAMPLE ALL PEAKS VALUES ARE QUITE HOMOGENEOUS. HOWEVER, THE CALIBRATOR ALL PEAKS VALUES ARE QUITE HETEROGENEOUS. BASED IN THESE FINDINGS, THE SPOT PREPARATION HAS TO BE VERIFIED WITH THE USER. KNOWLEDGE BASE REVIEW: PAENIBACILLUS ODORIFER IS NOT PRESENT IN EITHER THE VITEK MS KB V3.2 OR IN THE SARAMIS V4.16 (RUO DATABASE). ROOT CAUSE: THE CAUSE FOR NOT OBTAINING THE EXPECTED IDENTIFICATION HAS BEEN DETERMINED TO BE A SYSTEM LIMITATION AS PAENIBACILLUS ODORIFER IS NOT PRESENT IN EITHER THE VITEK MS KB V3.2 OR IN THE SARAMIS V4.16 (RUO DATABASE). THE USER MANUAL SUPPLEMENT FOR THE VITEK MS KB V3.2 INCLUDES A DOCUMENTED LIMITATION STATING THAT TESTING OF SPECIES NOT FOUND IN THE DATABASE MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. CONCLUSION: THE MISIDENTIFICATIONS WERE DETERMINED TO BE A RESULT OF THE ORGANISM NOT BEING PRESENT IN THE KNOWLEDGE BASES USED DURING TESTING. BIOM¿RIEUX ASSESSED THE RISK ASSOCIATED WITH THIS ISSUE AND DETERMINED THAT THE OVERALL RISK IS IRRELEVANT. TWO CHANGE REQUESTS HAVE BEEN INITIATED, ONE TO IMPROVE PREVOTELLA ORIS AND ONE TO ADD PAENIBACILLUS ODORIFER TO A FUTURE VITEK MS KNOWLEDGE BASE VERSION.

    Description of Event or Problem · 1

    THIS IS A COMPLAINT FROM BIOM¿RIEUX SUBSIDIARY FROM SOUTH KOREA WHO REPORTED OBTAINING MISIDENTIFICATIONS OF PAENIBACILLUS ODORIFER AS PREVOTELLA ORIS AND PAENIBACILLUS DURUS IN ASSOCIATION WITH THE VITEK¿ MS (REF. 410895, SERIAL NUMBER (B)(4)). THE SUBSIDIARY REPRESENTATIVE PERFORMED A BLIND TEST ON A BACTERIAL STRAIN AT A CUSTOMER'S SITE, USING THE IVD MODE OF THE VITEK MS. NO IDENTIFICATION WAS OBTAINED FOR SEVERAL TESTS BEFORE OBTAINING A RESULT OF PREVOTELLA ORIS. THE IDENTIFICATION OF PREVOTELLA ORIS DID NOT ALIGN WITH THE EXPECTED IDENTIFICATION, AS P. ORIS IS AN ANAEROBIC BACTERIUM AND THE STRAIN WAS INCUBATED IN AEROBIC CONDITIONS. IN THE CONTEXT OF TROUBLESHOOTING PERFORMED BY THE LOCAL CUSTOMER SERVICE AND, BECAUSE THE KNOWLEDGE BASE IS DIFFERENT, THE RESEARCH USE ONLY (RUO) MODE WAS USED IN ORDER TO SEE IF IT WAS POSSIBLE TO IDENTIFY THE ISOLATE. THE RESULT WAS PAENIBACILLUS DURUS. THE SEQUENCING OF THE 16S RRNA GENE GAVE PAENIBACILLUS ODORIFER WHICH IS THE SAME GENUS FOUND WITH THE RESEARCH USE ONLY MODE ON VITEK MS. PAENIBACILLUS ODORIFER IS NOT PRESENT IN IVD NOR RUO KNOWLEDGE BASES. AS IT WAS A TECHNICAL TEST, NO PATIENT SAMPLE WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577505 VITEK MS VITEK® MS QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1