BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW - VITEK MS RP5800 ACQ PC KIT CLI

    MDR report key: 6622599 · Received June 8, 2017

    Report

    Report Number
    3002769706-2017-00130
    Event Type
    Injury
    Date Received
    June 8, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    PEX
    PMA / PMN Number
    K124067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF CORYNEBACTERIUM SIMULANS AS CORYNEBACTERIUM DIPHTHERIA FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (ARROW - VITEK MS RP5800 ACQ PC KIT CLI) . AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. SUMMARY OF DATA ANALYZED: FOUR (4) SAMPLE MZML TESTED ON (B)(6) 2017. EIGHTEEN (18) ECAL MZML FROM (B)(6) 2017. ISSUE DATE: 24MAR2017. LAST FINE-TUNING DATE: 16MAR2017. CONCLUSION ON THE SYSTEM: SYSTEM WAS NOT OPERATIONAL DURING THE TEST. CONCLUSION ON THE IDENTIFICATION: REGARDING THE CUSTOMER DATA, THE MOST PROBABLE IDENTIFICATION IS CORYNEBACTERIUM SIMULANS. THIS IDENTIFICATION WAS CONFIRMED BY 16S SEQUENCING (REFERENCE METHOD). THE EXPECTED IDENTIFICATION WAS OBTAINED WITH VITEK® MS KNOWLEDGE BASE V2.0 AFTER A NEW FINE TUNING. SUSPECTED ROOT CAUSE OF THE ISSUE: NON-OPTIMAL FINE TUNING.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE NETHERLANDS REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF CORYNEBACTERIUM SIMULANS AS CORYNEBACTERIUM DIPHTHERIA FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (ARROW - VITEK MS RP5800 ACQ PC KIT CLI) . THE CUSTOMER REPORTED THE VITEK® MS IDENTIFIED CORYNEBACTERIUM DIPHTHERIA (99.8%) AND THE REFERENCE LAB RESULT WAS CORYNEBACTERIUM DIPHTHERIAE BY 16S SEQUENCING. THE CUSTOMER STATED THE INCORRECT RESULT WAS REPORTED TO THE PHYSICIAN, HOWEVER DUE TO THE RESULT, NO TREATMENT WAS GIVEN UNTIL THE FINAL RESULT WAS RECEIVED FROM THE REFERENCE LAB. THE FINAL ANSWER HAD A DELAY OF SEVERAL WEEKS. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405431 ARROW - VITEK MS RP5800 ACQ PC KIT CLI ARROW - VITEK MS RP5800 ACQ PC KIT CLI PEX BIOMERIEUX, S.A. 418884

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention