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

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of neisseria gonorrhoeae as neisseria cineria in association with the vitek® 2 nh test kit.The customer reported the vitek® 2 nh card result was neisseria cineria (99%).The customer stated the test was performed from martin lewis agar (bd) and gc agar (bd), and the plate was incubated for 18-24 hours with co2.A gram stain was performed and specific diplococci-like neisseria gonorrhoeae was observed.Testing with api® nh produced a result of neisseria species, and the specific api® profile test was still in process at the time of reporting.Pcr testing gave a result of neisseria gonorrhoeae, however this testing was from an agar plate, which is not the valid test method.The customer repeated the testing of isolates on martin lewis agar, and reported that isolates incubated less than 24 hours were not identified by vitek® 2 as expected.The last isolate with incubation time of 24 hours, produced two kinds of colonies, a small and a larger one.The vitek® 2 identification for the small and large colonies was slashline and neisseria gonorrhoeae, respectively.The customer reported incorrect results were not reported to a physician and there was no impact to patient results or treatment.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported a misidentification of neisseria gonorrhoeae as neisseria cinerea in association with the vitek® 2 nh id card lot #2450014203.The strain was identified as neisseria gonorrhoeae by pcr.The customer did not comply with biomérieux's request for strain or raw data submission.Biomérieux investigation was conducted.The customer reported testing the strains from martin-lewis and gc agar with strains incubated for 20 hours in co2 at 36c.Gc agar is not a recommended media according to the vitek® 2 nh id product labeling.The customer noted that the correct identification was obtained when retested from martin-lewis agar with a 24 hour old strain.One lab report was submitted which showed an excellent identification of neisseria cinerea with four (4) atypical negative reactions (arga, tyra, appa, dglu) for an identification of neisseria gonorrhoeae according to the nh id knowledge base.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error (e.G.Use of non recommended media) or an atypical strain.Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.For fastidious species such as neisseria gonorrhoeae, 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 id card when out of co2 for an extended period of time.Evaluation of the manufacturing qc batch record for nh id lot #2450014203 indicated the lot passed qc performance testing and met final qc release criteria.No ncmr was written against this lot.Ncmrs were reviewed for the last 13 months (20sep2016-20oct2017); no ncmrs were written for the nh id card.The investigation concluded there is no evidence to suggest a performance issue with vitek® 2 nh id card lot #2450014203.

• Brand Name: VITEK® 2 NH TEST KIT
• Type of Device: VITEK® 2 NH TEST CARD
• 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6606077
• MDR Text Key: 76603492
• Report Number: 1950204-2017-00169
• Device Sequence Number: 1
• Product Code: JST
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: C1, EXEMPT
• 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: 12/18/2017

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: 12/10/2017
• Device Catalogue Number: 21346
• Device Lot Number: 2450014203
• Other Device ID Number: 03573026144357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• 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