BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT - 410895

    MDR report key: 10793455 · Received November 5, 2020

    Report

    Report Number
    9615754-2020-00177
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATA FILES FROM THE CUSTOMER'S VITEK® MS WERE ANALYZED BY GLOBAL CUSTOMER SERVICE (GCS). THE DATA INDICATED THE FINE-TUNING STATUS WAS NOT OPTIMAL DURING THE TESTS PERFORMED BY THE CUSTOMER. SEVERAL MANDATORY CRITERIA WERE NOT MET. THE CALIBRATOR SAMPLE SPOT PREPARATION BY THE CUSTOMER WAS NON-OPTIMAL. THE ¿ALL PEAKS¿ VALUES ARE QUITE HETEROGENEOUS. THIS COULD BE EXPLAINED BY A NON-OPTIMAL SPOT PREPARATION OF THE CALIBRATOR STRAIN (CULTURE, SPOT, USER). THE EXPECTED ORGANISM IDENTIFICATION WAS NOT CONFIRMED BY THE CUSTOMER VIA REFERENCE TEST METHOD (SEQUENCING), AND MAY NOT BE INCLUDED IN THE VITEK® MS (B)(4) KB. THE VITEK® MS SYSTEM IS NOT A REFERENCE IDENTIFICATION METHOD. HOWEVER, BASED ON VITEK® MS RETEST, IT COULD BE ESCHERICHIA COLI WHICH IS INCLUDED IN THE VERSION (B)(4) KB. THE POTENTIAL MISIDENTIFICATION TO SERRATIA PROTEAMACULANS WAS OBTAINED: WITH A LOW IDENTIFICATION SCORE (-0.28) WHICH IS NEAR THE LIMIT FOR GIVING AN ¿IDENTIFICATION¿ RESULT RATHER THAN A ¿NO IDENTIFICATION¿ RESULT (-0.4). WITH THE SPECTRA HAVING THE LOWEST NUMBER OF PEAKS (44). BASED ON THE FINE TUNING ANALYSIS AND THE SPOT QUALITY ANALYSIS, THE MOST PROBABLE CAUSE OF THE ISSUE WAS DUE TO A NON-OPTIMAL FINE TUNING, AGGRAVATED BY A NON-OPTIMAL SPOT PREPARATION. SUSPECTED CAUSE RETAINED: NON OPTIMAL FINE TUNING; NON OPTIMAL SPOT PREPARATIONSEE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION OF A PATIENT ISOLATE IN ASSOCIATION WITH THE VITEK® MS (410985, SERIAL NUMBER (B)(4)) WITH KNOWLEDGE BASE (KB) (B)(4). AFTER 24 HOURS OF INCUBATION ON BLOOD AGAR, THE ISOLATE WAS IDENTIFIED AS SERRATIA PROTEAMACULANS BY THE VITEK® MS. THE CUSTOMER STATED THAT THE MORPHOLOGY OF THE SUBCULTURE AND THE ANTIBIOTIC RESISTANCE PROFILE WERE NOT CONSISTENT WITH THE IDENTIFICATION RESULT OBTAINED WITH VITEK MS. THE CUSTOMER STATED THAT, BASED ON THE MORPHOLOGY AND THE ANTIBIOTIC RESISTANCE PROFILE, THE STRAIN WOULD BE ESHERICHIA COLI. THE CUSTOMER INDICATED THAT THE TECHNICIAN TOOK A SECOND SAMPLE FROM THE SAME BLOOD AGAR (PURE ISOLATE) AFTER 48 HOURS OF INCUBATION; TESTING OF THIS ISOLATE VIA VITEK® MS OBTAINED AN ORGANISM IDENTIFICATION TO E.COLI 99.9%. NO ALTERNATE/REFERENCE METHOD OF ID TESTING WAS PERFORMED BY THE CUSTOMER. THE CUSTOMER INDICATED TO BIOMÉRIEUX THAT THE DISCREPANT RESULT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260343 VITEK MS INSTRUMENT - 410895 VITEK MS INSTRUMENT - 410895 QBN BIOMÉRIEUX SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1