BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NH TEST KIT

    MDR report key: 7142263 · Received December 22, 2017

    Report

    Report Number
    1950204-2017-00479
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Report Date
    March 23, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JST
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A NEISSERIA GONORRHOEAE EXTERNAL QUALITY CONTROL SAMPLE (EEQ) AS NEISSERIA MENINGITIDES IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED SETTING UP A 24 HOUR CULTURE FROM PVX THAT HAD BEEN INCUBATED IN CO2. TWO LAB REPORTS WERE SUBMITTED AND BOTH SHOWED AN EXCELLENT IDENTIFICATION OF N. MENINGITIDIS. ONE LAB REPORT SHOWED THREE (3) ATYPICAL NEGATIVE REACTIONS (ARGA, TYRA, APPA) AND THE SECOND LAB REPORT SHOWED TWO (2) ATYPICAL NEGATIVE REACTIONS (TYRA, APPA) FOR AN IDENTIFICATION OF N. GONORRHOEAE ACCORDING TO THE NH KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. HOWEVER WITHOUT THE STRAIN, LAB REPORTS OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. FOR FASTIDIOUS SPECIES SUCH AS N.GONORRHOAEAE, IT IS IMPORTANT TO LIMIT THE AMOUNT OF TIME THE CULTURE IS OUT OF CO2. THIS SPECIES WILL BEGIN TO SHOW DECREASED VIABILITY AND THEREFORE LESS REACTIVITY IN THE NH CARD WHEN OUT OF CO2 FOR AN EXTENDED PERIOD OF TIME. THE VITEK 2 NH LOT # 2450361203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A NEISSERIA GONORRHOEAE EXTERNAL QUALITY CONTROL SAMPLE (EEQ) AS NEISSERIA MENINGITIDES IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT. THE CUSTOMER TESTED THE SAMPLE TWICE WITH THE NH CARD AND THE RESULT WAS NEISSERIA MENINGITIDES (97%). THE EXPECTED RESULT WAS NEISSERIA GONORRHOEAE. THE CUSTOMER TESTED A CAMPYLOBACTER AS THE INTERNAL QUALITY CONTROL WHICH PASSED. THERE WAS NO PATIENT INVOLVEMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921368 VITEK® 2 NH TEST KIT VITEK® 2 NH TEST KIT JST BIOMERIEUX, INC 2450361203

    Patients

    Seq Age Sex Outcome Treatment
    1