BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GN TEST KIT

    MDR report key: 6170375 · Received December 13, 2016

    Report

    Report Number
    1950204-2016-00201
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Report Date
    March 27, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    JTO
    PMA / PMN Number
    C1, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION OF HERBASPIRILLUM HUTTIENSE AS BURKHOLDERIA CEPACIA IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT (LOT # 241386240). A REPEAT TEST PROVIDED A RESULT OF ACINETOBACTER LWOFFI. A BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE SEQUENCING RESULT OF THE CUSTOMER ISOLATE IS IN FAVOR TO THE SPECIES HERBASPIRILLUM HUTTIENSE (100%). THE ORGANISM WAS SUBCULTURED ON CBA (COLUMBIA BLOOD AGAR) AND TESTED ON THREE (3 ) GN ID CARDS (1 CUSTOMER LOT 241386240 + 2 RANDOM LOTS). THE RESULTS OBTAINED ON THE THREE CARDS WERE A SLASHLINE BURKHOLDERIA CEPACIA GROUP. THE INVESTIGATION DID NOT REPRODUCE THE MISIDENTIFICATION TO ACINETOBACTER IWOFII BUT REPRODUCED THE MISIDENTIFICATION OF BURKHOLDERIA CEPACIA GROUP (SPECIES VERY CLOSE). THE SPECIES HERBASPIRILLUM HUTTIENSE IS NOT IN THE KNOWLEDGE BASE OF VITEK® 2 (V7.01). THE VITEK® 2 PRODUCT INFORMATION MANUAL STATES THE FOLLOWING FOR GRAM-NEGATIVE IDENTIFICATION: "NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE GN DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION." THE INVESTIGATION CONCLUDED THE VITEK® 2 GN ID TEST KIT PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF HERBASPIRILLUM HUTIENSE AS BURKHOLDERIA CEPACIA IN ASSOCIATION WITH THE VITEK® 2 GN TEST KIT. REPEAT TESTING OF THE ISOLATE GAVE THE RESULT OF ACINETOBACTER LWOFFII. THE CUSTOMER TESTED THE ISOLATE USING THE BRUKER MALDI METHOD AND RECEIVED A RESULT OF HERBASPIRILLUM HUTIENSE. THE CUSTOMER REPORTED A DELAY OF GREATER THAN 24 HOURS DUE TO MULTIPLE RETESTS. THE CUSTOMER PROVIDED THE IDENTIFICATION RESULT AS NONFERMENTERS TO THE PHYSICIAN AS NO PRELIMINARY RESULT WAS REPORTED. THERE WAS NO IMPACT TO THE PATIENT'S HEALTH OR TREATMENT. HERBASPIRILLUM HUTIENSE IS A LIMITATION OF THE KNOWLEDGE BASE FOR VITEK® 2 IDENTIFICATIONS. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821453 VITEK® 2 GN TEST KIT VITEK® 2 GN TEST CARD JTO BIOMERIEUX INC. 241386240

    Patients

    Seq Age Sex Outcome Treatment
    1