BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 6824768 · Received August 28, 2017

    Report

    Report Number
    1950204-2017-00282
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Report Date
    November 10, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQM
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A PSEUDOMONAS AERUGINOSA ISOLATE AS A LOW DISCRIMINATION BURKHOLDERIA SPECIES IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. AN INVESTIGATION WAS PERFORMED. A REVIEW OF QUALITY RECORDS CONFIRMED THAT GN LOT# 2410064103 MET FINAL QC RELEASE CRITERIA AND PASSED INITIAL QC PERFORMANCE TESTING. THE CUSTOMER REPORTED SETTING UP THE ORGANISM FROM BLOOD AGAR. NO OTHER SET UP INFORMATION WAS GIVEN. THREE LAB REPORTS WERE SUBMITTED. THE FIRST LAB REPORT SHOWED AN ACCEPTABLE IDENTIFICATION OF B. CEPACIA GROUP WITH EIGHT (8) ATYPICAL POSITIVE REACTIONS (LARL, DCEL, DMAL, PLE, DSOR, SAC, DTAG, DTRE) FOR AN IDENTIFICATION OF P. AERUGINOSA ACCORDING TO THE GN KNOWLEDGE BASE. THE SECOND LAB REPORT WAS PARTIALLY CUT OFF SO THAT THE IDENTIFICATION RESULT AND HOUR OF CALL COULD NOT BE SEEN. HOWEVER, THE RESULTS FOR THE BIOCHEMICAL WELLS WERE PRESENT. THE LAB REPORT WAS LABELED AS A REPEAT. THERE WERE EIGHT (8) ATYPICAL POSITIVE REACTIONS (LARL, DCEL, DMAL, PLE, DSOR, SAC, DTAG, DTRE) FOR AN IDENTIFICATION OF P. AERUGINOSA ACCORDING TO THE GN KNOWLEDGE BASE. AN ASSESSMENT OF ANY ATYPICAL NEGATIVE REACTION COULD NOT BE MADE SINCE THE HOUR OF CALL WAS NOT AVAILABLE. THE THIRD LAB REPORT WAS LABELED AS SECOND RUN AND SHOWED AN ACCEPTABLE IDENTIFICATION OF B. CEPACIA GROUP WITH SEVEN (7) ATYPICAL POSITIVE REACTIONS (LARL, DCEL,, PLE, DSOR, SAC, DTAG, DTRE) FOR AN IDENTIFICATION OF P. AERUGINOSA ACCORDING TO THE GN KNOWLEDGE BASE. ALTHOUGH THIS LOT WAS ASSOCIATED WITH FSCA 3445 (VITEK® CARD POUCH INTEGRITY), NONE OF THE LAB REPORTS CONTAINED AN ATYPICAL UREA POSITIVE REACTION WHICH COULD BE AN INDICATOR OF A POUCH INTEGRITY ISSUE. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS OR AN ATYPICAL STRAIN. REVIEW OF INFORMATION RECORDED FOR THE COMPLAINT DID NOT REVEAL IF CONTAMINATION HAD BEEN RULED OUT AS A SOURCE OF THE MANY ATYPICAL POSITIVE REACTIONS. HOWEVER WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A PSEUDOMONAS AERUGINOSA ISOLATE AS A LOW DISCRIMINATION BURKHOLDERIA SPECIES IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE CUSTOMER REPORTED THAT THE FIRST ISOLATE WAS CONFIRMED BY A REFERENCE LAB AS PSEUDOMONAS AERUGINOSA. THE CUSTOMER STATED THE SECOND ISOLATE WAS IDENTIFIED BY VITEK® GN AS A LOW DISCRIMINATION BURKHOLDERIA SPECIES. THE GN TEST WAS REPEATED WITH THE SECOND ISOLATE TAKEN FROM A BAP PLATE, AND THE RESULT WAS BURKHOLDERIA SPECIES. THE CUSTOMER SENT THE ORGANISM TO A REFERENCE LAB. 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
    603641 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST CARD LQM BIOMERIEUX, INC 2410064103

    Patients

    Seq Age Sex Outcome Treatment
    1