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 (b)(6) notified biomérieux of misidentification of a suspected campylobacter bacterium as neisseria cinerea in association with vitek® 2 nh card.The customer performed an identification test on gram negative spiral bacteria with the vitek® 2 nh card.The bacterium, which was identified as neisseria cinerea, had been found from human feces and had grown on a selective media for campylobacter.This customer experienced 2 strains with same results.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) had notified biomérieux of obtaining mis-identification results for two strains of campylobacter as neisseria cinerea with the vitek® 2 nh card, lot #2450185403.The strains were identified as campylobacter or helicobacter by selective media (pourmedia modified skirrow) and confirmatory tests of catalase positive, oxidase positive, and growth at 42c.An internal biomérieux investigation was performed.The customer submitted one of the two strains for evaluation.The isolate received from customer was no longer viable and raw data was not available.The customer reported testing the isolates from sheep blood agar (nissui) with 18-24hr cultures.No other set up information was provided.The customer indicated the expected identification was either campylobacter or helicobacter on the submittal form.Two lab reports were submitted.Both showed identifications of n.Cinerea (very good and acceptable results).Since it is not known which species of campylobacter the strains were, an analysis of atypical results could not be performed.Generally, campylobacter species are more reactive in the nh card than n.Cinerea.Approximately 4-6 reactions are positive for campylobacter species compared to n.Cinerea in the card according to the nh knowledge base.If the strains were helicobacter, this is a species not claimed by the nh card and unidentified or mis-identification of an unclaimed species may occur as noted in the package insert.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.Nh lot# 2450185403 met final qc release criteria.This lot passed initial 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; saint louis MO 63042
• MDR Report Key: 6744655
• Report Number: 1950204-2017-00238
• Device Sequence Number: 19175485
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450185403
• 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: 06/29/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1