BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NH TEST KIT

    MDR report key: 6526229 · Received April 27, 2017

    Report

    Report Number
    1950204-2017-00131
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Report Date
    July 10, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    K842587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION OF (B)(6) AS KINGELLA DENITRIFICANS IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT. AN INVESTIGATION WAS PERFORMED. THE REFERENCE METHOD (SEQUENCING FULL 16S) WAS USED TO DETERMINE THE INTENDED RESULT, AND GAVE AN EXCELLENT IDENTIFICATION TO THE SPECIES (B)(6). VITEK® 2 NH CARDS WERE TESTED FROM THE CUSTOMER LOT (CL : 2450075203) AND A RANDOM LOT (RL : 2450061203). BOTH LOTS GAVE AN EXCELLENT IDENTIFICATION TO THE SPECIES (B)(6). THE MISIDENTIFICATION TO KINGELLA DENITRIFICANS WAS NOT DUPLICATED. A REVIEW OF THE CUSTOMER'S KINGELLA DENITRIFICANS DATA AGAINST EXPECTED REACTIONS FOR (B)(6) DEMONSTRATED 2 ATYPICAL (B)(6) REACTIONS (ARGA AND TYRA) AND 1 ATYPICAL (B)(6) REACTION (ELLM) ACCORDING TO THE NH KNOWLEDGE BASE, CONTRIBUTING TO THE MISIDENTIFICATION. AN INCREASED NUMBER OF ATYPICAL RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. THE INCREASED NUMBER OF ATYPICAL NEGATIVE REACTIONS MAY HAVE BEEN CAUSED BY LEAVING THE ISOLATE OUT OF CO2 FOR AN EXTENDED PERIOD OF TIME. SINCE (B)(6) IS A FASTIDIOUS SPECIES, IT NEEDS TO BE CONTAINED IN A CO2 ENVIRONMENT TO RETAIN ROBUSTNESS. IF THIS SPECIES IS LEFT OUT ON THE BENCH OUTSIDE OF CO2 FOR EXTENDED PERIODS, IT WILL BECOME LESS ROBUST AND THEREFORE LESS REACTIVE IN THE NH CARD. THE INVESTIGATION CONCLUDED THE VITEK® 2 NH TEST KIT PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF A MISIDENTIFICATION OF NEISSERIA GONORRHOEAE AS KINGELLA DENITRIFICANS, WHEN TESTING A VAGINAL SAMPLE IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT (UDI (B)(4)). THE CUSTOMER REPORTED THE ISOLATE WAS CULTURED ON PVX (POLYVITEX) MEDIA AND INCUBATED FOR 48 HOURS AT 37°C. IT WAS THEN TESTED WITH VITEK® 2 NH AND THE RESULT WAS KINGELLA DENITRIFICANS (99%). THE CUSTOMER STATED THE STRAIN GREW ON VCAT3 (CHOCOLATE AGAR POLYVITEX) MEDIA AND WAS OXIDASE POSITIVE. THE ISOLATE WAS THEN TESTED WITH AN API® NH TEST STRIP AND THE IDENTIFICATION WAS NEISSERIA GONORRHOEAE (98.5%). THE CUSTOMER RETESTED WITH A SUBCULTURE AFTER 48 HOUR INCUBATION AND THE VITEK® 2 NH IDENTIFIED NEISSERIA GONORRHOEAE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306645 VITEK® 2 NH TEST KIT VITEK® 2 NH TEST CARD JTO BIOMERIEUX, INC 2450075203

    Patients

    Seq Age Sex Outcome Treatment
    1