BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 COMPACT

    MDR report key: 12350129 · Received August 20, 2021

    Report

    Report Number
    1950204-2021-00050
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Report Date
    August 27, 2021
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K050002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN POLAND NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION IN ASSOCIATION WITH THE VITEK 2 GN ID CARD, LOT 2411483103. LAB REPORT 1: ISOLATE 500000-1 GN LOT 2411553103 ID= UNIDENTIFIED. EXPECTED ACINETOBACTER BAUMANII. NOTE: A RESULT OF "UNIDENTIFIED ORGANISM" IS A VALID RESULT FROM THE VITEK 2 SOFTWARE; THE ORGANISM GROWTH PATTERN DOES NOT CORRESPOND TO ANY TAXON IN THE KNOWLEDGE BASE. THIS BEHAVIOR DOES NOT CONSTITUTE A MALFUNCTION. LAB REPORT 2: ISOLATE 500001-1 GN LOT 2411483103. ID = SLASH-LINE BURKHOLDERIA CEPACIA GROUP (INCLUDED B. CEPACIA). EXPECTED P. AERUGINOSA. THE AWARENESS DATE OF THE MISID IS 06JUL2021 DURING THE VITEK 2 SYSTEMS SOFTWARE V9.02 UPDATE VISIT. BIOMÉRIEUX REPLACED THE ENTIRE COMPACT INSTRUMENT ON (B)(6) 2021. AFTER THE FSE REPLACED THE INSTRUMENT, THE CUSTOMER'S IDENTIFICATION ISSUES HAVE RESOLVED. THE IMPACTED STRAIN WAS NOT REQUESTED FOR INVESTIGATION. A REVIEW OF THE CUSTOMER'S BURKHOLDERIA CEPACIA GROUP RESULTS DEMONSTRATED NINE ATYPICAL POSITIVE REACTIONS (ADO, IARL, DCEL, DMAL, PLE, DSOR, SAC, DTAG, DTRE) FOR AN IDENTIFICATION OF P. AERUGINOSA ACCORDING TO THE GN KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS COULD INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA OR INSTRUMENT ISSUE. GN ID, LOTS 2411483103 AND 2411553103 MET FINAL QC RELEASE CRITERIA. THE LOTS PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 0

    INTENDED USE: THE VITEK® 2 COMPACT SYSTEM IS INTENDED FOR LABORATORY USE BY TRAINED, PROFESSIONAL, CLINICAL AND INDUSTRIAL USERS. THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NONFERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. DESCRIPTION OF THE PROBLEM: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING MISIDENTIFICATION OF P. AERUGINOSA AS BURKHOLDERIA CEPACIA IN ASSOCIATION WITH THE PRODUCT VITEK 2 COMPACT 30 (REF. 27415U, SERIAL NUMBER (B)(4)). THE VITEK 2 CARD TYPE ASSOCIATED WITH THIS COMPLAINT IS THE VITEK 2 GN ID TEST KIT (REF. 21341, LOT 2411483103). GLOBAL CUSTOMER SERVICE (GCS) REVIEW OF THE SUBMITTED LAB REPORTS INDICATED: AN "UNIDENTIFIED" RESULT FOR THE INITIAL TEST. A RESULT OF "UNIDENTIFIED ORGANISM" IS A VALID RESULT FROM THE VITEK 2 SOFTWARE; THE ORGANISM GROWTH PATTERN DOES NOT CORRESPOND TO ANY TAXON IN THE KNOWLEDGE BASE. THIS IS A DESIGNED BEHAVIOR, AND DOES NOT CONSTITUTE A MALFUNCTION. LAB REPORT 1: ISOLATE 500000-1 GN LOT 2411553103 ID= UNIDENTIFIED, EXPECTED P. AERUGINOSA. A SLASH-LINE RESULT WHICH INCLUDED THE CORRECT B. CEPACIA ORGANISM ID. A SLASH-LINE OR LOW-DISCRIMINATION IDENTIFICATION THAT INCLUDES THE EXPECTED IDENTIFICATION (B. CEPACIA, IN THIS CASE) IS NOT CONSIDERED A MISIDENTIFICATION AND IS AN ACCEPTABLE RESULT FOR THE VITEK® 2 GN ID TEST KIT. THERE IS NO MALFUNCTION ASSOCIATED WITH THIS EVENT. THE VITEK® 2 GN ID TEST KIT PERFORMED AS INTENDED. LAB REPORT 2: ISOLATE 500001-1 GN LOT 2411483103 ID= SLASHINE BURKHOLDERIA CEPACIA GROUP (INCLUDED B. CEPACIA) EXPECTED B. CEPACIA. AS THE CUSTOMER INDICATES "OTHER" MISIDENTIFIED ORGANISMS HAVE OCCURRED, BIOMÉRIEUX REPLACED THE VITEK 2 COMPACT INSTRUMENT. ACCORDING TO THE CUSTOMER, SAMPLES TESTED SINCE INSTRUMENT REPLACEMENT HAVE OBTAINED CORRECT ORGANISM IDENTIFICATIONS. THOUGH THE TEST RESULTS (LAB REPORTS) PROVIDED BY THE CUSTOMER DO NOT SHOW EVIDENCE OF A PRODUCT MALFUNCTION (I.E. A "NO ID" IN ONE CASE, AND A LOW-DISCRIMINATION INCLUDING THE CORRECT RESULT IN THE OTHER CASE), THIS EVENT WILL BE REPORTED AS A MALFUNCTION DUE TO THE CUSTOMER'S CLAIM OF MISIDENTIFICATION OF P. AERUGINOSA AS BURKHOLDERIA CEPACIA. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243756 VITEK 2 COMPACT VITEK® 2 COMPACT LON BIOMERIEUX, INC. 27415U

    Patients

    Seq Age Sex Outcome Treatment
    1