BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM POSITIVE TEST KIT

    MDR report key: 7119046 · Received December 14, 2017

    Report

    Report Number
    1950204-2017-00453
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Report Date
    July 19, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) HAD CONTACTED BIOMÉRIEUX TO REPORT THE MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS LUGDUNENSIS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED; HOWEVER, A VIABLE STRAIN WAS NOT RECEIVED FOR THE INVESTIGATION. THE CUSTOMER REPORTED SETTING UP THE STRAIN (FROM SEVERAL SAMPLES FROM THE SAME PATIENT) ON CBA INCUBATED FOR 24 HOURS AT 37C IN AMBIENT AIR. IT WAS NOTED THAT PURITY, OPTICS AND DENSICHEK WERE INDICATED AS BEING OK. THERE WERE NO ISSUES WITH SAMPLES FROM OTHER PATIENTS. TWELVE (12) LAB REPORTS WERE SUBMITTED. THE FOLLOWING LAB REPORTS ALL SHOWED VERY GOOD IDENTIFICATIONS OF S. LUGDENENSIS WITH TWO (2) ATYPICAL NEGATIVE REACTIONS (AGLU, PHOS) FOR AN IDENTIFICATION OF S. AUREUS ACCORDING TO THE VITEK GP KNOWLEDGE BASE: THREE (3) FROM (B)(6) 2017. TWO (2) FROM (B)(6) 2017. ONE (1) FROM (B)(6) 2017. ONE (1) FROM (B)(6) 2017. ONE (1) LAB REPORT FROM (B)(6) 2017 SHOWED A GOOD IDENTIFICATION OF S. AUREUS, AND TWO (2) LAB REPORTS SHOWED A LOW DISCRIMINATION IDENTIFICATION BETWEEN S. AUREUS AND S. LUGDUNENSIS, WHICH IS CONSIDERED TO BE A CORRECT CALL. ONE (1) LAB REPORT FROM (B)(6) 2017 SHOWED A VERY GOOD IDENTIFICATION OF STAPHYLOCOCCUS PSEUDINTERMEDIUS WITH THREE (3) ATYPICAL REACTIONS (PHOS-, URE+, DMAN-) FOR AN IDENTIFICATION OF S. AUREUS ACCORDING TO THE VITEK GP KNOWLEDGE BASE. ATYPICAL REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, COMPROMISED VIABILITY OF THE STRAIN, USE OF NON-RECOMMENDED MEDIA, OTHER USER SET UP ERRORS, OR AN ATYPICAL STRAIN. HOWEVER, WITHOUT THE STRAIN OR RAW DATA, IT WAS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. THE VITEK 2 GP ID TEST KIT LOT 2420460203 MET FINAL QC RELEASE CRITERIA AND PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS LUGDUNENSIS IN ASSOCIATION WITH THE VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT. ARTICULAR BONE SAMPLES WERE PROCESSED VIA VITEK® 2 GP ID CARD. THE RESULT OBSERVED WAS STAPHYLOCOCCUS LUGDUNENSIS. SINCE THE LABORATORY TECHNICIAN SUSPECTED STAPHYLOCOCCUS AUREUS FROM AGGLUTINATION TEST, SHE REPEATED THE TEST VIA DIFFERENT LOT OF GP ID CARD; THE SAME RESULT WAS OBTAINED. TESTING AT A DIFFERENT LABORATORY VIA ALTERNATE METHOD (MASS SPECTOMETRY) PROVIDED A RESULT OF STAPHYLOCOCCUS AUREUS. THE CUSTOMER INDICATES A DELAY OF 48 HOURS IN REPORTING RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896787 VITEK® 2 GRAM POSITIVE TEST KIT VITEK® 2 GP TEST KIT LQL BIOMERIEUX INC. 2420460203 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1