BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NEISSERIA-HAEMOPHILUS TEST KIT

    MDR report key: 5261181 · Received December 2, 2015

    Report

    Report Number
    1950204-2015-00108
    Event Type
    Malfunction
    Date Received
    December 2, 2015
    Report Date
    November 11, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    K842587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    TWO ISOLATES FROM THE SAME PATIENT WERE SUBMITTED. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. TESTING FOR EACH ISOLATE INCLUDED: VITEK® 2 NH ID (CUSTOMER LOT). VITEK® 2 NH ID (RANDOM LOT). API® NH. 16S SEQUENCING. VITEK® MS. ISOLATE 1: VITEK® 2 NH ID (CUSTOMER LOT) - UNIDENTIFIED ORGANISM· VITEK® 2 NH ID (RANDOM LOT) - ACCEPTABLE ID (86%) OF HAEMOPHILUS INFLUENZAE. API® NH - ACCEPTABLE ID TO GENUS, WITH A 76.1% IDENTIFICATION OF HAEMOPHILUS INFLUENZAE AND A 23.8% IDENTIFICATION OF HAEMOPHILUS PARAINFLUENZAE. 16S SEQUENCING - HAEMOPHILUS INFLUENZAE. VITEK® MS - HAEMOPHILUS INFLUENZAE. ISOLATE 2: VITEK® 2 NH ID (CUSTOMER LOT) - UNIDENTIFIED ORGANISM. VITEK® 2 NH ID (RANDOM LOT) - UNIDENTIFIED ORGANISM. API® NH - ACCEPTABLE ID TO GENUS, WITH A 76.1% IDENTIFICATION OF H. INFLUENZAE AND A 23.8% IDENTIFICATION OF H. PARAINFLUENZAE. 16S SEQUENCING - HAEMOPHILUS INFLUENZAE. VITEK® MS- HAEMOPHILUS INFLUENZAE. THE CUSTOMER'S RESULT OF HAEMOPHILUS PARAINFLUENZAE WAS NOT REPRODUCED. THE RESULTS OF UNIDENTIFIED ARE ACCEPTABLE FOR VITEK® 2 TESTING WHEN THE TEST KIT REACTIONS DO NOT MATCH THE REACTIONS IN THE VITEK® 2 NH ID KNOWLEDGE BASE, AND PROMPT THE USER TO PERFORM AN ALTERNATE METHOD OF TESTING. THE VITEK® 2 NH ID TEST KITS PERFORMED IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THE VITEK 2 NEISSERIA HAEMOPHILUS (NH) ID TEST KIT (REF 21346) MISIDENTIFIED A HAEMOPHILUS INFLUENZA ORGANISM AS HAEMOPHILUS PARAINFLUENZA. TWO BLOOD CULTURES WERE OBTAINED FROM A PATIENT WHO WAS PREGNANT AND HAD LOST THE BABY. THE BLOOD CULTURES GREW AS HAEMOPHILUS. THE PHYSICIAN REQUESTED TESTING BE PERFORMED TO OBTAIN A COMPLETE ORGANISM IDENTIFICATION. THE ORGANISM WAS TESTED VIA VITEK 2 NH ID TEST KIT AND THE BRUKER INSTRUMENT (BEING EVALUATED AT THE CUSTOMER SITE, NOT YET IN SERVICE). THE ORGANISM WAS PROCESSED THREE (3) TIMES USING THE VITEK 2 NH ID; THE FIRST RESULT WAS REPORTED AS "UNIDENTIFIED", THE REMAINING TESTS REPORTED HAEMOPHILUS PARAINFLUENZA. THE ORGANISM WAS IDENTIFIED IN THE BRUKER INSTRUMENT AS HAEMOPHILUS INFLUENZA. A THIRD TEST WAS PERFORMED (FACTOR DISKS). THE ORGANISM GREW ONLY IN THE PRESENCE OF BOTH FACTORS X AND V, AND NOT IN THE PRESENCE OF EITHER ONE SEPARATELY. THESE RESULTS PROVIDE EVIDENCE OF HAEMOPHILUS INFLUENZA BEING THE CORRECT RESULT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED FROM THE CUSTOMER FOR INVESTIGATION. INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790122 VITEK® 2 NEISSERIA-HAEMOPHILUS TEST KIT VITEK® 2 NH ID TEST KIT JTO BIOMERIEUX, INC 245352920

    Patients

    Seq Age Sex Outcome Treatment
    1