BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT

    MDR report key: 6784344 · Received August 10, 2017

    Report

    Report Number
    1950204-2017-00258
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Report Date
    October 23, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JST
    UDI-DI
    03573026144357
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE CUSTOMER REPORTED TESTING THE ISOLATE FROM PVX MEDIA WHICH HAD BEEN INCUBATED AT 37C IN CO2. THE PERCENTAGE OF CO2 USED WAS NOT REPORTED. THE CUSTOMER REMARKED THE CARD WAS SET UP RIGHT AFTER THE STRAIN WAS REMOVED FROM THE CO2 INCUBATOR. THREE (3) LAB REPORTS WERE SUBMITTED. THE FIRST LAB REPORT SHOWED AN EXCELLENT IDENTIFICATION OF N. CINEREA WITH 3 ATYPICAL NEGATIVE REACTIONS (TYRA, APPA, DGLU) AND ONE ATYPICAL POSITIVE REACTION (ELLM) FOR AN IDENTIFICATION OF N. GONORRHOEAE ACCORDING TO THE NH KNOWLEDGE BASE. THE OTHER 2 LAB REPORTS SHOWED LOW DISCRIMINATION IDENTIFICATIONS BETWEEN N. GONORRHOEAE AND N. ELONGATA. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MIS-IDENTIFICATION. NH LOT# 245398920 MET FINAL QC RELEASE CRITERIA. THE LOT PASSED INITIAL QC PERFORMANCE TESTING.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF NEISSERIA GONORRHOEAE AS NEISSERIA CINEREA IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. DUE TO SUSPICION OF NEISSERIA GONORRHOEAE BASED ON GRAM STAIN AND CLINICAL PRESENTATION, THE CUSTOMER PERFORMED PCR TESTING AND OBTAINED THE NEISSERIA GONORRHOEAE RESULT. THE CUSTOMER STATED THE DISCREPANT VITEK® 2 NH ID RESULT WAS NOT REPORTED TO THE TREATING PHYSICIAN; THE PCR RESULT WAS USED BY THE PHYSICIAN FOR TREATMENT DECISIONS. THERE WAS NO ADVERSE IMPACT ON THE PATIENT'S STATE OF HEALTH DUE TO THE DISCREPANT RESULT. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. HOWEVER, THE CUSTOMER STATED THE STRAIN IS NO LONGER VIABLE FOR TESTING. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566973 VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID TEST KIT JST BIOMERIEUX, INC 245398920 03573026144357

    Patients

    Seq Age Sex Outcome Treatment
    1