BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 6262452 · Received January 18, 2017

    Report

    Report Number
    1950204-2017-00013
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Report Date
    September 15, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    C1, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE ORGANISM WAS TESTED ON MULTIPLE LOTS OF GN CARDS IN DUPLICATE, INCLUDING FOUR (4) LOTS REPORTED BY CUSTOMERS AND ONE (1) RANDOM GN LOT. THE API 20 E WAS PERFORMED, AS WAS THE VITEK® MS. ON TWO (2) OF THE CUSTOMER LOTS, A LOW DISCRIMINATION CALL OF P. PENNERI / P. HAUSERI WAS OBTAINED. ON THE REMAINING TWO (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.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF AN API PROFICIENCY TEST URINE SAMPLE OF PROTEUS VULGARIS, AS PROTEUS PENNERI IN ASSOCIATION WITH THE VITEK® 2 GN ID TEST KIT. THE ORGANISM WAS CULTURED 24-48 HOURS ON BAP/TSAB/BLOOD AGAR, USING MCFARLAND RANGE 0.5-0.63. THE CUSTOMER REPEATED THE TEST WITH AN 18-24 HOUR CULTURE, USING MCFARLAND 0.60 AND 0.57. THE IDENTIFICATION RESULT WAS PROTEUS PENNERI. THE VITEK®2 GN TEST REPORTS AND THE PROFICIENCY RESULTS WERE REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44421 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST CARD JTO BIOMERIEUX, INC 241373140

    Patients

    Seq Age Sex Outcome Treatment
    1