BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11863285 · Received May 21, 2021

    Report

    Report Number
    9615754-2021-00165
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF WICKERHAMOMYCES ANOMALUS AS CANDIDA PELLICULOSA WHEN USING THE VITEK® MS SYSTEM, REFERENCE 410895, SERIAL NUMBER #(B)(4). INVESTIGATION RESULTS: FINE TUNING: FINE TUNING WAS NOT WITHIN SPECIFICATION, SEVERAL MANDATORY CRITERIA WERE NOT ACHIEVED. SPOT PREPARATION QUALITY: THE CALIBRATOR ¿ALL PEAKS¿ VALUES ARE QUITE HETEROGENEOUS AND, THEREFORE, NOT OPTIMAL. THE SAMPLE ¿ALL PEAKS¿ ARE HOMOGENEOUS. KNOWLEDGE BASE REVIEW: WICKERHAMOMYCES ANOMALUS IS THE SEXUAL FORM (TELEOMORPH) OF CANDIDA PELLICULOSA. THE EXPECTED IDENTIFICATION, WICKERHAMOMYCES ANOMALUS, IS PRESENT UNDER THE NAME OF CANDIDA PELLICULOSA (ASEXUAL FORM ¿ ANAMORPH). SAMPLE DATA ANALYSIS: ANALYSIS OF SPECIMEN DATA FILES DETERMINED THAT THE NUMBER OF ALL PEAKS ARE HOMOGENEOUS DURING THE ISSUE. THE MISIDENTIFICATION WAS OBTAINED WITH AN ACCEPTABLE IDENTIFICATION SCORE. LOCAL CUSTOMER SERVICE RECOMMENDED ACTIONS : - CHECK SAMPLE PREPARATION WITH THE CUSTOMER TO HELP HIM TO IMPROVE HIS SPOT PREPARATION TECHNIQUE (VIDEO, TRAINING, ¿ ) - PERFORM A NEW FINE TUNING RESPECTING THE FINE TUNING PROCEDURE. CONCLUSION : A SYSTEM MALFUNCTION HAS NOT BEEN CONFIRMED. VITEK MS GAVE THE EXPECTED IDENTIFICATION AS CANDIDA PELLICULOSA IS THE ASEXUAL FORM (ANAMORPH) OF WICKERHAMOMYCES ANOMALUS. NO PROBLEM HAS BEEN DETECTED REGARDING THE STRAIN : WICKERHAMOMYCES ANOMALUS.

    Description of Event or Problem · 0

    INTENDED USE. THE VITEK® MS SYSTEM, REFERENCE 410895, IS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF WICKERHAMOMYCES ANOMALUS AS CANDIDA PELLICULOSA WHEN USING THE VITEK® MS SYSTEM, REFERENCE 410895, SERIAL NUMBER #(B)(4). IDENTIFICATION OF THE STRAIN USING DNA SEQUENCING METHOD OBTAINED WICKERHAMOMYCES ANOMALUS. WICKERHAMOMYCES ANOMALUS IS NOT IN THE VITEK MS KB 3.0 DATABASE; VITEK MS PROVIDED AN INCORRECT ORGANISM ID TO CANDIDA PELLICULOSA. NO INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER REGARDING ANY POTENTIAL PATIENT IMPACT OF THE MISIDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759100 VITEK MS INSTRUMENT VITEK MS INSTRUMENT QBN BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1