BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS

    MDR report key: 10678388 · Received October 14, 2020

    Report

    Report Number
    9615754-2020-00158
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Report Date
    December 28, 2020
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN INDIA REGARDING TWO (2) MISIDENTIFICATIONS OF MYCOBACTERIUM CHELONAE AS MYCOBACTERIUM ABSCESSUS IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (REF 410895). THE MISIDENTIFICATIONS WERE IDENTIFIED DURING REVIEW OF A SCIENTIFIC PUBLICATION ENTITLED, "EPIDEMIOLOGY AND RISK FACTORS ASSOCIATED WITH NTM PULMONARY AND EXTRAPULMONARY INFECTIONS IN A HIGH TUBERCULOSIS ENDEMIC REGION". BOTH ISOLATES WERE IDENTIFIED BY HAIN CM AS M. CHELONAE, BUT WERE IDENTIFIED AS M. ABSCESSUS BY MALDI-TOF MS. THE MANUFACTURER INSTRUCTIONS FOR USE WERE SAID TO BE FOLLOWED: THERE IS NOTHING WHICH CONTRADICTS THIS IN THE PUBLICATION. ADDITIONAL INFORMATION WAS ASKED TO LOCAL CUSTOMER SERVICE (LCS) IN ORDER TO INVESTIGATE ON THE QUALITY OF SPECTRA. HOWEVER, LCS INFORMED BIOMÉRIEUX THAT THE VITEK® MS PC HAVING THE ASSOCIATED MZML FILES (OF THREE YEARS PREVIOUS) HAD BEEN REPLACED BY THE FIELD SERVICE ENGINEER (FSE). THEREFORE, ADDITIONAL DATA COULD NOT BE PROVIDED FOR THE INVESTIGATION. THE IDENTIFICATION QUALITY COULD NOT BE ANALYZED. BASED ON THE RULES FOR CLOSURE OF OUR LOCAL PROCEDURE, A DECISION WAS MADE TO CLOSE THE INVESTIGATION DUE TO IMPOSSIBILITY TO INVESTIGATE. WITHOUT THE CUSTOMER¿S RAW DATA, NO INVESTIGATION CAN BE DONE.

    Description of Event or Problem · 1

    AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A SCIENTIFIC PUBLICATION ENTITLED, "EPIDEMIOLOGY AND RISK FACTORS ASSOCIATED WITH NTM PULMONARY AND EXTRAPULMONARY INFECTIONS IN A HIGH TUBERCULOSIS ENDEMIC REGION" BY WANI, SR ET AL. THIS PUBLICATION NOTED TWO (2) MISIDENTIFICATIONS OF MYCOBACTERIUM CHELONAE AS MYCOBACTERIUM ABSCESSUS IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (REF 410895). THE STUDY COMPARED IDENTIFICATION RESULTS OF THE GENOTYPE MYCOBACTERIA CM ASSAY TO THOSE OBTAINED BY THE VITEK® MS WHEN TESTING NON-TUBERCULOUS MYCOBACTERIA (NTM) SAMPLES. OUT OF 60 NTM ISOLATES ANALYZED WITH THE VITEK® MS, THE VITEK® MS OBTAINED MISIDENTIFICATIONS FOR TWO (2) OF THE ISOLATES. IT IS NOT STATED IF THE TWO ISOLATES THAT WERE MISIDENTIFIED WERE COLLECTED FROM DIFFERENT PATIENTS OR FROM THE SAME PATIENT. THERE IS NO INDICATION OR REPORT FROM THE AUTHORS THAT ANY RESULTS OBTAINED DURING THIS STUDY WERE USED FOR DIAGNOSIS AND/OR TREATMENT DECISIONS FOR ANY PATIENTS. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144492 VITEK MS VITEK® MS QBN BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1