BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11631002 · Received April 7, 2021

    Report

    Report Number
    9615754-2021-00042
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INVESTIGATOR REVIEWED THE HISTORICAL RECORDS (BACK TO JANUARY 2016) IN THE COMPLAINTS DATABASE TO DETERMINE WHETHER OTHER SIMILAR REPORTS HAVE BEEN DOCUMENTED. SINCE JANUARY 2016, ONE (1) SIMILAR COMPLAINT HAS BEEN RECORDED FOR A PSEUDOMONAS AERUGINOSA MISIDENTIFIED AS PSEUDOMONAS PUTIDA. THE EXPECTED IDENTIFICATION WAS UNKNOWN AS NO IDENTIFICATION REFERENCE METHOD WAS PERFORMED (SEQUENCING). NO EXISTING CAPAS NOR NON-CONFORMITIES WERE IDENTIFIED THAT COULD BE LINKED WITH THIS REPORT. AMONG THIRTY-ONE (31) ISOLATES OF PSEUDOMONAS AERUGINOSA, VITEK MS MISIDENTIFIED ONE ISOLATE AS PSEUDOMONAS PUTIDA AND REPORTED FIVE (5) ISOLATES AS "NO IDENTIFICATION." LOCAL CUSTOMER SERVICE REQUESTED FURTHER INFORMATION FROM THE CUSTOMER. FOLLOWING SEVERAL ATTEMPTS TO COLLECT ADDITIONAL INFORMATION, THE CUSTOMER WAS UNABLE TO PROVIDE ANY OTHER RELEVANT DATA OR SAMPLES OF THE ISOLATES IN QUESTION. CONCLUSION. VITEK MS IDENTIFIED P. AERUGINOSA USING THE KNOWLEDGE BASE VERSION 3.0 DATABASE. NO REFERENCE METHOD (I.E. SEQUENCING) WAS USED TO CONFIRM THE ORGANISM IDENTIFICATION, THUS THE ACTUAL SPECIES REMAINS UNKNOWN. ROOT CAUSE. CAUSE NOT ESTABLISHED - ROOT CAUSE COULD NOT BE ESTABLISHED DUE TO LACK OF ADDITIONAL INFORMATION AND LACK OF ACCESS TO ANY OF THE MENTIONED SAMPLES. CORRECTIVE AND PREVENTATIVE ACTION. NO CAPA NUMBER IS REQUIRED AS THE ROOT CAUSE CANNOT BE DETERMINED AND THERE IS NO EVIDENCE THAT THIS IS A RECURRING OR SYSTEMIC QUALITY ISSUE.

    Description of Event or Problem · 1

    AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2021 SCIENTIFIC PUBLICATION ENTITLED, "PERFORMANCE OF TDR-300B AND VITEKVR 2 FOR THE IDENTIFICATION OF PSEUDOMONAS AERUGINOSA IN COMPARISON WITH VITEKVR-MS" BY MOEHARIO, L.H. ET AL. THE AUTHORS USED THE VITEK® MS (REF. 410895) WITH KNOWLEDGE BASE 3.0 AS GOLD STANDARD FOR IDENTIFICATION OF 31 PSEUDOMONAS AERUGINOSA ISOLATES IN COMPARISON WITH TWO OTHER METHODS (TDR-300B WITH NF-64 CARD AND VITEK® 2 WITH VITEK® 2 GN CARD). AMONG THE 31 ISOLATES, THE VITEK® MS IDENTIFIED 25 ISOLATES CORRECTLY, FIVE (5) ISOLATES WERE NOT IDENTIFIED AND THERE WAS ONE (1) MISIDENTIFICATION. FOR THE MISIDENTIFICATION, THE RESULT GIVEN BY THE VITEK® MS WAS PSEUDOMONAS PUTIDA INSTEAD OF P. AERUGINOSA. P. AERUGINOSA IS PRESENT IN THE KNOWLEDGE BASE 3.0. AS IT WAS A SCIENTIFIC PUBLICATION, NO PATIENT SAMPLE WAS INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525472 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1