MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NH TEST KIT

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomérieux to report discrepant results in association with the vitek® 2 nh test kit (ref.21346), while testing a qc isolate of neisseria gonorrhoeae atcc 19424.The customer obtained a result of neisseria cinerea organism at 99%, however the expected result is neisseria gonorrhoeae.There is no indication or report from the customer to biomérieux that the discrepant result led to any adverse impact to a patient's state of health.The media used by the customer was chocolate pvx (chocolate polyvitex agar) media after 18-24h of incubation and after 48h of incubation.In both cases the result was neisseria cinerea.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported the occurrence of a misidentification of (b)(6) (atcc® 19424¿) as neisseria cinerea in association with the vitek® 2 nh identification test kit (card).The customer submitted the (b)(6) (atcc® 19424¿) sample for investigational testing.The investigation included testing of three (3) nh id card lots with the customer strain and the internal biomérieux strain: customer lot 245390220 (cl1) tested twice on both strains.Customer lot 2450185403 (cl2) tested twice on both strains.Random lot 245398920 (rl) tested twice on both strains.Isolates were subcultured as indicated in the package insert.The internal strain (all card lots) obtained identification to (b)(6).The customer strain (all card lots) obtained identification to (b)(6).The investigation did not reproduce the customer results for the customer strain nor the internal reference strain whatever the lot tested.After comparison of biochemical profiles between expected results and the profile obtained by the customer (identification to neisseria cinerea), the investigation observed two (2) discrepant tests (false negative arga and appa).An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.An 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 outside of co2 for extended periods, it will become less robust and therefore less reactive in the nh id card.The investigation concluded the vitek® 2 nh id card is performing as intended.

• Brand Name: VITEK® 2 NH TEST KIT
• Type of Device: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6412578
• MDR Text Key: 70318928
• Report Number: 1950204-2017-00090
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K842587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450185403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1