BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 6682107 · Received June 30, 2017

    Report

    Report Number
    1950204-2017-00209
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Report Date
    October 10, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    CI EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE ORGANISM WAS SUBBED AND TESTING INCLUDED BOTH THE CUSTOMER LOT AND A RANDOM LOT OF GN CARDS, TESTED IN DUPLICATE. API 20 NE WAS ALSO PERFORMED. ON ALL CARDS TESTED, AN EXCELLENT IDENTIFICATION OF P. AERUGINOSA WAS OBTAINED. API 20 NE ALSO GAVE AN EXCELLENT IDENTIFICATION OF P. AERUGINOSA. A COMPARISON OF CARD REACTION RESULTS FOR BURKHOLDERIA CEPACIA GROUP AGAINST EXPECTED REACTION RESULTS FOR P. AERUGINOSA RESULTED IN 10 ATYPICAL POSITIVE REACTIONS (ADO, IARL, DCEL, DMAL, PLE, DSOR, SAC, DTAG, DTRE, PHOS) WHICH LED TO THE MISIDENTIFICATION. A COMPARISON OF CARD REACTION RESULTS FOR BURKHOLDERIA PSEUDOMALLEI AGAINST EXPECTED REACTION RESULTS FOR P. AERUGINOSA RESULTED IN SIX (6) ATYPICAL POSITIVE REACTIONS (DCEL, PLE, DSOR, SAC, DTAG, DTRE) THAT LED TO THE MISIDENTIFICATION. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA, USER SET UP ERRORS, OR AN ATYPICAL STRAIN. CARDS ARE PERFORMING AS EXPECTED AND NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION ASSOCIATED WITH THE VITEK® 2 GN TEST KIT INVOLVING PSEUDOMONAS ARUGINOSA ATCC 27853. THE CUSTOMER REPORTED TESTING FOUR (4) TIMES USING THE VITEK® 2 GN CARD AND IDENTIFYING THE ORGANISM AS BURKHOLDERIA WITH VARYING DEGREES OF PROBABILITY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461342 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST KIT LQM BIOMERIEUX INC. 21341 2410125103 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1