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

Catalog Number	21346
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported a misidentification of (b)(6) as neisseria meningitides in association with the vitek® 2 nh test kit.The customer stated the initial identification of n.Meningitides was reported to the physician.The physician requested that the isolate be retested as they believed it to be (b)(6), and the patient was being treated for it.The customer performed repeat testing with the nh card from the original plate, as there was not enough growth for the required mcfarland range.A low discrimination result was received, which did not include (b)(6).The isolate was sent out to a reference lab which reported that the isolate was dead and no identification could be made.The customer stated the isolate is no longer available.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.
Additional Manufacturer Narrative
A customer in the united states reported a misidentification of neisseria gonorrhea as neisseria meningitides in association with the vitek® 2 nh test kit.An internal biomérieux investigation was performed.The customer reported setting up an 18-24 hour old isolate from chocolate agar that had been incubated at 36c in co2.Three (3) lab reports were submitted.The lab report labeled initial run showed an excellent identification of n.Meningitidis with five (5) atypical reactions (arga-, ggt+, proa-, tyra-, appa-) for an identification of n.Gonorrhoeae according the nh knowledge base.A second lab report was noted to be a re-test of the isolate.A note appeared on the lab report that the test was "run on an old plate - did not have enough organism to get required mcfarland".The lab report showed a low discrimination result for n.Cinerea and n.Meningitidis with five (5) atypical negative reactions (arga, proa, tyra, appa, dglu) for an identification of n.Gonorrhoeae according the nh knowledge base.A third lab report was noted to be a known isolate and not the patient isolate.The lab report showed a low discrimination result for n.Cinerea, n.Elongata, and n.Gonorrhoeae, which would be considered a correct result for n.Gonorrhoeae.An increased number of atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non-recommended media or other user set up errors, or an atypical strain.For the repeat testing of the isolate, the potential misidentification was most likely due to the age of culture being out of range and insufficient mcfarland density.However, without the strain or raw data it is not possible to further evaluate the cause of the misidentification.For fastidious species such as n.Gonorrhoaeae, 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 card when out of co2 for an extended period of time.A note will be added in 8.01 software that will state "possibility of n.Gonorrohoeae" when an identification of n.Cinerea is reported.Vitek 2 nh test kit lot #2450361203 met final qc release criteria and passed qc performance testing.

• Brand Name: VITEK® 2 NH TEST KIT
• Common Device Name: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7355105
• Report Number: 1950204-2018-00111
• Device Sequence Number: 13746347
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450361203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1