BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11702219 · Received April 21, 2021

    Report

    Report Number
    9615754-2021-00087
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BIOMÉRIEUX, 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

    PUBLICATION 138835015 : EVALUATION OF AUTOF MS 1000 AND VITEK MS MALDI-TOF SYSTEM IN IDENTIFICATION OF CLOSELY-RELATED YEASTS CAUSING INVASIVE FUNGAL DISEASES. FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY . 2021 , 11 628828 YI QIAOLIAN, XIAO MENG, FAN XIN, ZHANG GE, YANG YANG, ZHANG JING-JIA, DUAN SI-MENG, CHENG JING-WEI, LI YING, ZHOU MENG-LAN, YU SHU-YING, HUANG JING-JING, CHEN XIN-FEI, HOU XIN, KONG FANRONG, KUDINHA TIMOTHY, XU YING-CHUN. INVESTIGATION: INITIALLY, THE INVESTIGATOR REVIEWED THE COMPLAINTS DATABASE TO IDENTIFY ANY SIMILAR CUSTOMER REPORTS. SINCE JANUARY 2016, NO SIMILAR COMPLAINT HAS BEEN RECORDED FOR CANDIDA PARAPSILOSIS, C. ORTHOPSILOSIS, C. METAPSILOSIS, C. NEOFORMANS AND C. GATTII. FOUR (4) SIMILAR COMPLAINTS WERE RECORDED FOR CANDIDA ALBICANS MISIDENTIFIED AS C. DUBLINIENSIS LINKED TO DIFFERENT CAUSES (AN OPERATOR ERROR, A SPOT PREPARATION ISSUE, A KB WEAKNESS AND A LACK OF FINE-TUNING MONITORING). THE ARTICLE COMPARES TWO MALDI-TOF COMMERCIAL METHODS , AUTOF MS 1000 AND VITEK MS KB V3.0 FOR THE IDENTIFICATION OF 1,228 YEASTS. NO INFORMATION REGARDING THE FINE-TUNING (WHEN IT WAS PERFORMED, DATA OBTAINED DURING TUNING, OR TUNING STATUS) OF THE VITEK® MS INSTRUMENT WAS PROVIDED IN THE PUBLICATION. THE ISOLATES WERE ALSO SEQUENCED (ITS SEQUENCING). SEQUENCING IS CONSIDERED TO BE THE GOLD STANDARD FOR ORGANISM CONFIRMATION. THE KNOWLEDGE BASE (KB) LIBRARY USED BY THE AUTHORS (V3.0) CONTAINS CLAIMS FOR CANDIDA PARAPSILOSIS AND C. ALBICANS. THE INFORMATION NEEDED TO DIFFERENTIATE CANDIDA METAPSILOSIS, C. NIVARIENSIS, C. BRACARENSIS, C. DUOBUSHAEMULONII, AND C. AURIS ISS NOT INCLUDED IN THAT KB VERSION. BIOMÉRIEUX LOCAL CUSTOMER SERVICE CONFIRMED THAT THE STUDY WAS PERFORMED TWO (2) YEARS AGO (2019), AND THAT DATA ARE NO LONGER AVAILABLE. THERE WERE NO PATIENTS HARMED/TREATED INCORRECTLY, NO INDIRECT PATIENT HARM REPORTED, NO PATIENTS OR OPERATORS HARMED AND NO PATIENT OR OPERATOR DEATH. CONCLUSION: AS ADDITIONAL DATA WERE NOT AVAILABLE, FURTHER INVESTIGATION CANNOT BE CONDUCTED. THE USE OF AN OLDER VERSION OF THE VITEK MS KNOWLEDGE BASE (V3.0) MAY CONTRIBUTE TO THE DIFFERENCE IN PERFORMANCE BETWEEN THE VITEK MS AND THE AUTOF MS 1000. VERSION 3.2 KNOWLEDGE BASE IS AVAILABLE AND CONTAINS IMPROVEMENTS FOR SPECIES, ESPECIALLY C. METAPSILOSIS AND C. ORTHOPSILOSI. ROOT CAUSE. CAUSE NOT ESTABLISHED. CORRECTIVE AND PREVENTATIVE ACTION. NO CAPA IS REQUIRED.

    Description of Event or Problem · 0

    AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A CHINESE SCIENTIFIC PUBLICATION ENTITLED "EVALUATION OF AUTOF MS 1000 AND VITEK MS MALDI-TOF MS SYSTEM IN IDENTIFICATION OF CLOSELY-RELATED YEASTS CAUSING INVASIVE FUNGAL DISEASES. FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY . 2021 , YI QIAOLIAN,ET AL. ". THIS PUBLICATION DOCUMENTS MISIDENTIFICATIONS OF YEAST ISOLATES BY THE VITEK MS: - 3 MISIDENTIFICATIONS OF C PARAPSILOSIS; C. ALBICANS (2), C. PELLICULOSA (1) - 29 MISIDENTIFICATIONS OF C METAPSILOSIS; C. PARAPSILOSIS (15), C. ORTHOPSILOSIS (5), C. PELLICULOSA (1), C. PULCHERRIMA (2), C. LAURENTII (1), L. ELONGISPORUS (4), P. ITALICUM (1) - 16 MISIDENTIFICATIONS OF C ORTHOPSILOSIS; C. PARAPSILOSIS (15), C. ALBICANS (1) - 8 MISIDENTIFICATIONS OF C ALBICANS; C. UTILIS (4), C. PARAPSILOSIS (1), C. TROPICALIS (1), C. GLABRATA/C. TROPICALIS/C. FAMATA (1), C. TROPICALIS/C. DUBLINIENSIS (1) - 2 MISIDENTIFICATIONS OF C NEOFORMANS; C. TROPICALIS (1), C. PARAPSILOSIS (1) - 2 MISIDENTIFICATIONS OF C GATTII AS C. NEOFORMANS - 1 MISIDENTIFICATION OF C GLABRATA AS C. PARAPSILOSIS - 1 MISIDENTIFICATION OF C NIVARIENSIS AS C. GLABRATA THE ARTICLE AIMS TO EVALUATE TWO COMMERCIALLY AVAILABLE MALDI-TOF SYSTEMS, AUTOF MS 1000 AND VITEK MS, FOR THE IDENTIFICATION OF YEASTS WITHIN CLOSELY-RELATED SPECIES COMPLEXES. ACCORDING TO THE ARTICLE, A TOTAL OF 1,228 YEAST ISOLATES CAUSING INVASIVE FUNGAL DISEASES COLLECTED FROM 57 HOSPITALS IN CHINA DURING THE PERIOD AUGUST 2016 TO JULY 2017 WERE STUDIED. ISOLATES WERE INITIALLY INOCULATED ON CHROMOGENIC AGAR, SUBCULTURED ON SABOURAUD DEXTROSE AGAR (SDA), AND INCUBATED AT 35°C FOR 24-48 HOURS. THEN, ISOLATES WERE TESTED ACCORDING TO INSTRUCTIONS FOR USE OF THE MALDI TOF METHODS. ALL ISOLATES WERE IDENTIFIED BY DNA SEQUENCING OF THE INTERNAL TRANSCRIBED SPACER (ITS) REGION, WHICH WAS CONSIDERED THE REFERENCE METHOD. SIXTY-THREE (63) STRAINS WERE REPORTED AS MISIDENTIFIED BY THE VITEK MS; HOWEVER, DETAILS OF THE RESULTS WERE PROVIDED FOR ONLY 62 STRAINS.. THERE IS NO INDICATION OR REPORT WITHIN THE PUBLICATION THAT ANY RESULTS OBTAINED DURING THE STUDY WERE USED FOR DIAGNOSIS OR TREATMENT DECISIONS FOR ANY PATIENT. THERE IS ALSO NO INDICATION OR REPORT OF ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602159 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1