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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event 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.

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
• 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: 6744655
• MDR Text Key: 81150002
• Report Number: 1950204-2017-00238
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 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
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2016
• 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