BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 7061452 · Received November 27, 2017

    Report

    Report Number
    1950204-2017-00421
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Report Date
    June 6, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT FOR A PROTEUS VULGARIS QUALITY CONTROL SURVEY STRAIN WHEN TESTED WITH THE VITEK® 2 GN ID TEST KIT, (REF. 21341) LOT 2410167203. ACCORDING TO THE CUSTOMER, VITEK® 2 GAVE AN IDENTIFICATION OF PROTEUS PENNERI OR PROTEUS HAUSERI FOR THE STRAIN. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE STRAIN AND RAW DATA WERE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER REPORTED SETTING UP THE STRAIN FROM BLOOD AGAR. NO OTHER SET UP INFORMATION WAS PROVIDED. THE CUSTOMER ALSO STATED THAT THE CARD WAS SET UP IMMEDIATELY AFTER REMOVAL FROM THE REFRIGERATOR. THE PRODUCT LABELING STATES THAT THE CARDS MUST BE ROOM TEMPERATURE BEFORE USE. ONE LAB REPORT WAS SUBMITTED SHOWING AN IDENTIFICATION OF P. HAUSERI WITH FIVE ATYPICAL NEGATIVE REACTIONS (BGLU, PROA, GGAA, PLE, URE) FOR AN IDENTIFICATION OF P. VULGARIS ACCORDING TO THE GN KNOWLEDGE BASE. NO LAB REPORT WAS SUBMITTED FOR AN IDENTIFICATION OF P. PENNERI. ATYPICAL NEGATIVE REACTIONS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. WITHOUT THE STRAIN OR RAW DATA, IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. VITEK 2 GN ID TEST KIT, LOT # 2410167203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT FOR A PROTEUS VULGARIS QUALITY CONTROL SURVEY STRAIN WHEN TESTED WITH THE VITEK® 2 GN ID TEST KIT, (REF. 21341) LOT 2410167203. ACCORDING TO THE CUSTOMER, VITEK® 2 GAVE AN IDENTIFICATION OF PROTEUS PENNERI OR PROTEUS HAUSERI FOR THE STRAIN. 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. THERE WAS NO PATIENT ASSOCIATED WITH THIS QC STRAIN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838304 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 2410167203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1