BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 7046088 · Received November 20, 2017

    Report

    Report Number
    1950204-2017-00408
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    February 16, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED MISIDENTIFICATIONS OF ACINETOBACTER BAUMANNII AS BURKHOLDERIA CEPACIA GROUP OR KLEBSIELLA OXYTOCA WHEN TESTING THE VITEK ® 2 GN CARD LOTS 2410267203 AND 2410259203 AND USING VITEK 2 SOFTWARE VERSION 7.01. THE STRAINS WERE IDENTIFIED AS ACINETOBACTER BAUMANNII BY THE API® 20E. STRAINS AND RAW DATA WERE NOT AVAILABLE FOR SUBMISSION TO BIOMÉRIEUX. THE CUSTOMER REPORTED SETTING UP THE STRAINS FROM COLUMBIA AGAR WITH 5% SHEEP BLOOD. NO INFORMATION WAS PROVIDED ABOUT AGE OF CULTURE OR INCUBATION CONDITIONS. IT WAS NOTED THAT THE CUSTOMER CLEANED THEIR SALINE DISPENSER BY DISMANTLING IT AND SOAKING IT IN ALCOHOL. THEY DO NOT AUTOCLAVE THEIR DISPENSER. NOTE: CLEANING A DISPENSER WITH ALCOHOL WILL CAUSE FALSE POSITIVE REACTIONS AND IS NOT RECOMMENDED. AN ARTICLE WAS PUBLISHED IN THE JOURNAL OF CLINICAL MICROBIOLOGY (2005, VOL. 43, NO.8) THAT SHOWED A. BAUMANNI MAY MISIDENTIFY AS K. OXYTOCA DUE TO ETHANOL CLEANING OF THE SALINE DISPENSER. LAB REPORTS FROM TWO PATIENTS WERE SUBMITTED. THE TWO (2) LAB REPORTS WERE SUBMITTED LABELED #P0133245-6. THE FIRST LAB REPORT SHOWED AN ACCEPTABLE IDENTIFICATION FOR BURKHOLDERIA CEPACIA GROUP WITH SIX (6) ATYPICAL POSITIVE REACTIONS (ADO, LARL, DMAN, DSOR, DTAG, DTRE) AND THE SECOND SHOWED AN EXCELLENT IDENTIFICATION OF K. OXYTOCA WITH EIGHT (8) ATYPICAL POSITIVE REACTIONS (ADO, LARL, DMAL, DMAN, DSOR, SAC, DTAG, DTRE) FOR AN IDENTIFICATION OF A. BAUMANNII ACCORDING TO THE GN KNOWLEDGE BASE. ONE (1) LAB REPORT WAS SUBMITTED LABELED P0113048-3 THAT SHOWED AN EXCELLENT IDENTIFICATION OF K. OXYTOCA WITH SEVEN (7) ATYPICAL POSITIVE REACTIONS (ADO, LARL, DMAL, DMAN, DSOR, DTAG, DTRE) FOR AN IDENTIFICATION OF A. BAUMANNII ACCORDING TO THE GN KNOWLEDGE BASE. 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. HOWEVER, IN THIS SITUATION, THE FALSE POSITIVE REACTIONS ARE MOST LIKELY DUE TO IMPROPER CLEANING OF THE SALINE DISPENSER WITH ALCOHOL. VITEK 2 GN TEST KIT LOT # 2410267203 AND 2410259203 MET FINAL QC RELEASE CRITERIA. THESE LOTS PASSED INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS FOR ACINETOBACTER SPECIES WHEN TESTING WITH VITEK® 2 GN ID TEST KIT (REF 21341). VITEK® 2 TESTED THE ISOLATES OF TWO PATIENTS AND OBTAINED THE FOLLOWING RESULTS: FOR PATIENT 1 ((B)(6)), SAMPLE 1, VITEK® 2 (LOT 2410259203) IDENTIFIED AS KLEBSIELLA OXYTOCA. REPORTED UNDER (B)(4). SAMPLE 2, VITEK® 2 (LOT 2410267203) IDENTIFIED AS BURKHOLDERIA (SLASHLINE). REPORTED UNDER (B)(4). API OBTAINED ACINETOBACTER (94%) IDENTIFICATION. FOR PATIENT 2 ((B)(6)), SAMPLE 1, VITEK® 2 (LOT 2410259203) IDENTIFIED AS KLEBSIELLA OXYTOCA. REPORTED UNDER (B)(4). API OBTAINED ACINETOBACTER BAUMANNII/CALCOACETICUS IDENTIFICATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO 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
    825370 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 2410259203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1