BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 6266493 · Received January 20, 2017

    Report

    Report Number
    1950204-2017-00019
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Report Date
    February 15, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    C1, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE ORGANISM WAS TESTED ON MULTIPLE LOTS OF GN CARDS IN DUPLICATE. 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). THIS IS AN ATYPICAL ISOLATE. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE DURING THE LAST 13 MONTH TIMEFRAME WITH NO IMPLICATION OF A TREND. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN API (AMERICAN PROFICIENCY INSTITUTE) SURVEY SAMPLE OF PROTEUS VULGARIS, AS PROTEUS PENNERI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. THE REPEATED TEST RESULT WAS PROTEUS PENNERI. THE CUSTOMER STATED THEY HAD A LOW DISCRIMINATION AND PERFORMED AN INDOLE TEST ON THE ORGANISM, WHICH WAS NEGATIVE INDICATING PROTEUS PENNERI. THE TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50368 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST CARD JTO BIOMERIEUX, INC 241391140

    Patients

    Seq Age Sex Outcome Treatment
    1