BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 7881251 · Received September 17, 2018

    Report

    Report Number
    1950204-2018-00367
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Report Date
    November 28, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES HAD REPORTED MISIDENTIFICATIONS OF THREE (3) STRAINS FROM DIFFERENT CYSTIC FIBROSIS PATIENTS IN ASSOCIATION WITH THE VITEK® 2 GN ID CARD. THE GN ID CARD IDENTIFIED THE STRAINS AS BORDETELLA HINZII FOR ALL THREE ISOLATES. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED USING THE ISOLATES SUBMITTED BY THE CUSTOMER. THE SUBMITTED STRAINS WERE SUBCULTURED AND TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH THE VITEK 2 GN CARD FROM THE CUSTOMER'S LOT (2410576403) AND A RANDOM LOT (2410445403) IN DUPLICATE. TWO (2) STRAINS WERE TESTED ON THE VITEK MS AND 16S SEQUENCING WAS ALSO PERFORMED FOR TWO (2) STRAINS. STRAIN 911729 (F13050-3): ALL FOUR (4) VITEK 2 GN CARDS GAVE UNIDENTIFIED ORGANISM RESULTS. VITEK MS RESULTED IN A LOW DISCRIMINATION IDENTIFICATION OF A. DENITRIFICANS (50.0)/ A. XYLOSOXIDANS (50.0). 16S SEQUENCING RESULTED IN A 100% IDENTITY MATCH FOR A. DENITRIFICANS. FOR THIS STRAIN, THE CUSTOMER'S MISIDENTIFICATION OF BORDETELLA HINZII WAS NOT DUPLICATED WHILE THE VITEK 2 RESULTS OF UNIDENTIFIED ORGANISM WERE INCORRECT. A REVIEW OF THE CUSTOMERS B. HINZII DATA REVEALED ONE ATYPICAL NEGATIVE REACTION (PYRA) FOR AN IDENTIFICATION OF ACHROMOBACTER DENITRIFICANS/XYLOSOXIDANS ACCORDING TO THE GN KNOWLEDGE BASE. ATYPICAL NEGATIVE REACTIONS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USE OF NON-RECOMMENDED MEDIA OR AN ATYPICAL STRAIN. THE ATYPICAL STRAIN (911729) WILL BE ADDED TO R&D'S STOCK COLLECTION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED MISIDENTIFICATIONS OF FOUR (4) STRAINS FROM THREE (3) CYSTIC FIBROSIS PATIENTS IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE GN CARD IDENTIFIED BORDETELLA HINZI FOR ALL FOUR (4) ISOLATES. A PHYSICIAN SUSPECTED THE IDENTIFICATION SHOULD BE ACHROMOBACTER, SO THREE (3) ISOLATES WERE SENT TO AN EXTERNAL LAB (ARUP) FOR IDENTIFICATION (MALDI-TOF). THE FOLLOWING IDENTIFICATIONS WERE OBTAINED: (B)(6) - ACHROMOBACTER SPECIES; (B)(6) - ACHROMOBACTER SPECIES; (B)(6) - KERSTERSIA GYIORUM. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO PATIENT TREATMENT, AND THE PHYSICIAN DID NOT ALLEGE THAT THE RESULTS CAUSED HIM TO ACT INCORRECTLY. IT WAS MENTIONED THAT PATIENT (B)(4) HAD BEEN ADMITTED TO A HOSPITAL A WEEK OR TWO PRIOR TO BEING SEEN IN THE CUSTOMER'S CLINIC. THE HOSPITAL IDENTIFIED AN ACHROMOBACTER (MALDI-TOF) FROM THE PATIENT'S SPUTUM. 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
    722393 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX, INC. 2410576403 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1