BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 6216011 · Received December 30, 2016

    Report

    Report Number
    1950204-2016-00217
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    February 14, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    C1, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED ON A API SURVEY ORGANISM (API PROFICIENCY URINE UR-11). THE ORGANISM WAS TESTED ON MULTIPLE LOTS OF GN CARDS IN DUPLICATE, INCLUDING 4 LOTS REPORTED BY CUSTOMERS AND 1 RANDOM GN LOT. THE API 20 E WAS PERFORMED, AS WAS THE VITEK® MS. ON 2 OF THE CUSTOMER LOTS, A LOW DISCRIMINATION CALL OF P. PENNERI / P. HAUSERI WAS OBTAINED. ON THE REMAINING 2 CUSTOMER LOTS TESTED AND THE RANDOM LOT, A LOW DISCRIMINATION CALL OF P. PENNERI / P. PNEUMOTROPICA WAS OBTAINED. API 20 E GAVE A GOOD IDENTIFICATION CALL OF P. VULGARIS GROUP. VITEK® MS GAVE A LOW DISCRIMINATION CALL OF P. PENNERI / P. VULGARIS. SINCE THE ORGANISM IS INDOLE POSITIVE, THE VITEK® MS CALL OF P. VULGARIS WOULD BE CORRECT. A COMPARISON OF REACTION RESULTS FOR CARDS GIVING THE MISIDENTIFICATION CALL OF P. PENNERI / P. HAUSERI AGAINST THE EXPECTED REACTION RESULTS FOR P. VULGARIS REVEALED 3 ATYPICAL NEGATIVE REACTIONS (PLE, ILATK, AGLU). A COMPARISON OF REACTION RESULTS FOR CARDS GIVING THE MISIDENTIFICATION CALL OF P. PENNERI/P. PNEUMOTROPICA AGAINST THE EXPECTED REACTION RESULTS FOR P. VULGARIS REVEALED 4 ATYPICAL NEGATIVE REACTIONS (PROA, PLE, ILATK, AGLU). THE INVESTIGATION CONCLUDED THE SUBMITTED ISOLATE EXHIBITS ATYPICAL GROWTH BEHAVIOR. THE VITEK® 2 GN TEST KIT PERFORMED AS INTENDED. .

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN AMERICAN PROFICIENCY INSTITUTE (API) SURVEY SAMPLE IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. THE API SAMPLE, PROTEUS VULGARIS, WAS IDENTIFIED WITH THE VITEK® 2 GN CARD AS LOW DISCRIMINATION FOR PROTEUS PENNERI/HAUSERI. THE CUSTOMER PERFORMED AN OFF LINE INDOLE TEST WHICH WAS POSITIVE, AND REPORTED THE RESULT AS PROTEUS HAUSERI. REPEAT TESTING WITH VITEK® 2 GN IDENTIFIED PROTEUS HAUSERI. THE CUSTOMER PROVIDED THE TEST REPORTS TO BIOMÉRIEUX FOR EVALUATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865373 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST CARD JTO BIOMERIEUX, INC 241390140

    Patients

    Seq Age Sex Outcome Treatment
    1