BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 5306197 · Received December 17, 2015

    Report

    Report Number
    1950204-2015-00126
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Report Date
    December 8, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE ARTICLE "FIRST REPORT OF WOHLFAHRTIIMONAS CHITINICLASTICA ISOLATION FROM A PATIENT WITH CELLULITIS IN THE UNITED STATES", DIOS ET AL. J. CLIN. MICROBIOL. DECEMBER 2015 ; 53:12 3942-3944 REPORTED THAT THE VITEK GN ID CARD IDENTIFIED A STRAIN OF WOHLFAHRTIIMONAS CHITINICLASTICA AS ACINETOBACTER LWOFFII. ACCORDING TO THE ARTICLE, THE IDENTIFICATION WAS CONFIRMED WITH MALDI-TOF AND 16S RRNA SEQUENCING. THE ARTICLE DID NOT CONTAIN THE GN ID CARD LOT NUMBER OR SOFTWARE VERSION IN USE BY THE CUSTOMER AT THE TIME OF TESTING. THE AUTHOR WOULD NOT SUBMIT THE ISOLATE FOR INTERNAL BIOMÉRIEUX INVESTIGATION. WOHLFAHRTIIMONAS CHITINICLASTICA IS A SPECIES THAT IS NOT CLAIMED BY THE GN ID CARD. THE AUTHORS REPORTED THAT THE STRAIN WAS NOT VERY REACTIVE IN THE GN ID CARD WITH ONLY THREE WELLS GIVING A POSITIVE REACTION (TYRA, ELLM, LLATK) WHICH MATCHED THE BIOCHEMICAL PROFILE FOR ACINETOBACTER LWOFFII IN THE GN ID KNOWLEDGE BASE. THE GN ID KNOWLEDGE BASE WILL ATTEMPT TO MATCH THE REACTIONS OF THE TEST ISOLATE TO CLAIMED BIOPATTERNS. IF AN UNCLAIMED SPECIES IS TESTED AND A CLOSE MATCH IS FOUND, A MISIDENTIFICATION CAN OCCUR. IF THE BIOPATTERN DOES NOT MATCH, A RESULT OF UNIDENTIFIED WILL BE REPORTED. IN THIS CASE, THE REACTIONS MATCH ACINETOBACTER LWOFFII SUFFICIENTLY ENOUGH TO REPORT THE IDENTIFICATION AS SUCH. THE GN ID CHAPTER IN THE VITEK 2 PRODUCT INFORMATION CONTAINS THE FOLLOWING WARNING IN THE LIMITATIONS SECTION: TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. THE VITEK 2 SYSTEM FUNCTIONED AS INTENDED AND IN ACCORDANCE WITH SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    AS A RESULT OF JOURNAL PUBLICATION REVIEW BY BIOMERIEUX MEDICAL AFFAIRS (UNITED STATES), MISIDENTIFICATION OF WOHLFAHRTIIMONAS CHITINICLASTICA WAS INDICATED IN ASSOCIATION WITH THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE ORGANISM WAS MISIDENTIFIED AS ACINETOBACTER LWOFFII. THERE IS NO STATEMENT BY THE AUTHOR(S) OF THE JOURNAL ARTICLE THAT ANY DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AS THE CLAIM IS THE GENERAL SUBJECT OF A JOURNAL ARTICLE, THERE IS/ARE NO CULTURE SUBMITTAL(S) AVAILABLE FOR BIOMERIEUX INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833253 VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD JTO BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1