MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT; VITEK® 2 NH ID TEST KIT

Catalog Number 21346

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).Biomérieux internal investigations were conducted for events #1, #2, #3, #5 and #6.For event #4, the investigation results are pending.Event #1: multilocus sequence typing (mlst) was performed to define the expected identification in comparison to the result on vitek® 2 nh cards (two different lots with subculture on cba and chocolat pvx with co2).Additional testing on vitek® ms current version (v2.0) and future version (v3.0) of knowledge base.Strain identified to species neisseria polysaccharea by mlst.The misidentification was duplicated on vitek® 2 nh cards to the species neisseria sicca as obtained from one customer.The species neisseria polysaccharea (expected identification) is not included in the vitek® 2 knowledge base.On vitek® ms, there was duplication of the identification to neisseria meningitidis with the current version (v2.0), but confirmed the good result of neisseria polysaccharea with the future version (v3.0).The vitek® 2 nh test kit product information limitation section indicates testing of unclaimed species may result in an unidentified organisms result or misidentification.Event #2: the isolate was subcultured and nh testing included 2 nh cards from the same lot as that tested by the customer, 2 cards from a random lot and the api nh.The 4 nh cards gave excellent identification calls of n gonorrhoeae and the api nh identification of n gonorrhoeae confirm the vitek 2 to be correct.The low discrimination call is an acceptable call so an evaluation of that data was not done.Review of the n meningitidis data against the expected reactions for n gonorrhoeae show there to be 2 atypical negative reactions.An increase number of atypical negative reactions may have been caused by leaving the isolate out of co2 for an extended period of time.Since n.Gonorrhoeae 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 nh cards are performing as expected and no further action is required.Event #3: the customer did not submit the strain; however, submitted two (2) laboratory reports.One lab report gave an 87% neisseria sicca acceptable identification.This lab report had five (5) atypical results for n.Gonorrhoeae according to the vitek® 2 nh knowledge base (dglu negative; positive: mte, odc, dmal,sac).The second lab report gave a 99% neisseria cinerea excellent identification.This lab report had three (3) atypical negative results for n.Gonorrhoeae according to the vitek® 2 nh knowledge base (tyra, appa, dglu).No documentation was submitted for the low discrimination result.An increase in atypical reaction can indicate an issue with the set up procedure, an atypical strain, mixed culture, contamination or decreased viability.Without the strain, raw data or set up information from the customer, it was not possible to further evaluate the cause of the misidentification.Event #5: the lab report showed 4 atypical negative reactions (arga, tyra, appa, dglu) for 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.Without the strain or raw data it's not possible to further evaluate the cause of the mis-identification.Event #6: the customer reported testing the strains from cba media at 24 hrs in a 37c, co2 atmosphere.The customer submitted 4 lab reports.One lab report showed a correct call (low discrimination) between c.Coli and c.Jejuni ssp jejuni.Two lab reports showed an identification of c.Coli.Both lab report showed 3 atypical negative reactions (mte, pyra, ops) for c.Jejuni ssp jejuni according to the nh knowledge base.One lab report showed an identification of n.Cinerea with 5 atypical negative reactions (mte, odc, lglm, pyra, ops) for c.Jejuni ssp jejuni according to the nh knowledge base.C.Jejuni ssp jejuni atcc 33560 was tested twice during nh development.Both tests gave a correct low discrimination id of c.Coli / c.Jejuni ssp jejuni.C.Jejuni ssp jejuni is an organism that requires a microaerophilic environment to sustain robust growth.The customer reported incubating the strain in co2, which would not be a sufficient atmosphere for this species.An increased number of atypical negative results (as was shown on the submitted lab reports) can indicate a strain with decreased viability, user set up error or an atypical strain.Based on the information provided it is most likely due to user error of an insufficient environment for this species.In addition, follow-up information was received for an initial case reported via the q1 pilot program summary report.Results are as follows: follow-up event: misidentification of campylobacter jejuni as campylobacter coli.Investigation concluded the strain to be atypical based upon the behavior exhibited when tested via the vitek® 2 system phenotypic ast testing method and the genetic measurement technique of 16s sequencing.

Event Description

This report summarizes "6" malfunction events.Exemption number (b)(4).A review of events indicated that testing via vitek® nh test kit resulted in misidentifications to include: misidentification of neisseria meniingitidis as neisseria gonorrhoeae and/or neisseria sicca involving a patient sample.Misidentification of neisseria gonnorrhoeae as neisseria meningitidis involving a patient sample.Misidentification of neisseria gonorrhoeae as neisseria cinerea involving a patient sample.Misidentification of campylobacter jejuni as neisseria cinerea involving a quality control sample.Misidentification of neisseria gonorrhoeae as neisseria cinerea involving a quality control sample.Misidentification of campylobacter jejuni as campylobacter coli involving a patient sample.For all six (6), there was no indication or report of adverse events or negative patient due to the discrepant results.In addition, follow-up information was received for a vitek® 2 nh test kit event reported initially via the pilot program q1 summary.

Manufacturer Narrative

Initial assessment of this report was performed under (b)(4) (submitted as part of the q2 pilot summary report 190204-2016-00064).This report was initially submitted following notification that a customer in (b)(6) reported a discrepant organism identification for campylobacter jejuni baa 1153-1 as neisseria cinerea in association with the vitek® 2 nh id test kit.The strain is no longer available for submission to biomérieux.The customer used the campylosel media in microphilia atmosphere.Campylosel is not a validated media for the vitek® 2 nh id test kit.The organism was incubated at 37c for 48 hours, which is not a recommended incubation time.After retest on cba media, the customer obtained the correct organism identification.The initial setup and incubation performed by the customer (campylosel media , 48 hour incubation) do not conform with the vitek® 2 nh id instructions for use, and can lead to misidentification.Evaluation of internal biomérieux test results for this strain indicate correct identification of campylobacter jejuni.No issues were observed.Investigational testing of the internal strain (customer strain not available for submission) was conducted via vitek® 2 nh id card, vitek® ms, pcr and api® campy, and all methods gave identifications of campylobacter jejuni ssp jejuni.The investigation concluded that the customer test conditions (media + incubation time) did not conform with the nh id card and lead to the misidentification.The vitek® 2 nh id card is performing as intended.Device not returned to manufacturer.

• Brand Name: VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 NH ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5828853
• MDR Text Key: 50624605
• Report Number: 1950204-2016-00064
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K842587
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2017
• Device Catalogue Number: 21346
• Device Lot Number: 245369520
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1