BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS

    MDR report key: 6789062 · Received August 11, 2017

    Report

    Report Number
    3002769706-2017-00243
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    May 9, 2017
    Report Date
    January 8, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: REGARDING THE DATA RECEIVED THE MOST PROBABLE IDENTIFICATION IS AEROMONAS SOBRIA/VERONII. HOWEVER, AS THE STRAIN WAS NOT AVAILABLE FOR FURTHER INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THE IDENTIFICATION. THE RESULT DISCREPANCIES OBSERVED BETWEEN VITEK® MS KNOWLEDGE BASE (KB) (B)(4) AND KB (B)(4) ARE DUE TO AN IMPROVEMENT MADE TO VITEK® MS KB (B)(4) REGARDING AEROMONAS SPECIES. AEROMONAS SOBRIA IS PART OF THE KB (B)(4) AND SINCE KB (B)(4), THE ORGANISM WAS IDENTIFIED BY A SLASHLINE RESULT AS AEROMONAS SOBRIA/VERONII. THIS MODIFICATION WAS MADE IN ORDER TO IMPROVE THE VITEK® MS PERFORMANCE AND AVOID ANY IDENTIFICATION ISSUES. THE RESULTS OBTAINED BY THE CUSTOMER WITH VITEK® MS ARE DESCRIBED BELOW: WITH KB (B)(4): AEROMONAS HYDROPHILA/CAVIAE. WITH VITEK® MS KB (B)(4): AEROMONAS SOBRIA/VERONII. IN ADDITION, THE KB USER MANUAL, REF. 161150-556-B FOR VITEK® MS CLINICAL USE (B)(4) MENTIONED THE FOLLOWING LIMITATIONS REGARDING AEROMONAS SPECIES: AEROMONAS HYDROPHILA/CAVIAE AND AEROMONAS SOBRIA SHOULD BE CONSIDERED AS AN AEROMONAS SPECIES GROUP IDENTIFICATION. SUBSPECIES OR SPECIES GROUP IS DISPLAYED AS A LOW DISCRIMINATION RESULT. A CHOICE SHOULD BE MADE BETWEEN THE PROPOSED SUBSPECIES OR SPECIES. THIS SPECIES IS ASSOCIATED WITH A HIGH LEVEL OF UNIDENTIFIED RESULTS. THE MOST PROBABLE ROOT CAUSE OF THE IDENTIFICATION ISSUE ENCOUNTERED IS THE NON-OPTIMAL SPOT PREPARATION AND A SYSTEM LIMITATION (REGARDING AEROMONAS SPECIES FOR VITEK® MS KB (B)(4)). IN ORDER TO OPTIMIZE THE PERFORMANCES ON THE VITEK® MS SYSTEM, OUR LOCAL BIOMÉRIEUX REPRESENTATIVE WILL PROVIDE THE CUSTOMER TRAINING MATERIALS TO IMPROVE SPOT PREPARATION TECHNIQUE.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A QUALITY CONTROL SAMPLE IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT. THE CUSTOMER REPORTED THAT ON (B)(6) 2017 A STRAIN OF ISOLATES ORIGINATING FROM THE REGIONAL NATURE CONTROL TEST, WAS IDENTIFIED AS AEROMONAS HYDROPHILA/PUNCTATA (CAVIAE) WITH VITEK® MS V2.0. IN (B)(6) 2017, THE SAME STRAIN ISOLATES WERE IDENTIFIED AS AEROMONAS SOBRIA/AEROMONAS VERONII WITH VITEK® MS V3.0. THE CUSTOMER STATED THE AEROMONAS SOBRIA/ AEROMONAS VERONII RESULT WAS CORRECT. THE CUSTOMER STATED THERE WAS NO PATIENT AFFECTED AS THE EVENT WAS A QUALITY CONTROL TEST. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568904 VITEK® MS VITEK® MS PEX BIOMERIEUX, SA 410895

    Patients

    Seq Age Sex Outcome Treatment
    1