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

Model 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 discrepant results associated vitek® 2 nh test kit (reference 21346).The customer reported that the vitek® 2 identified the strain as neisseria cinerea (94% probability) instead of campylobacter coli (result by a vitek® ms 99.9% probability).There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in switzerland reported a misidentification of campylobacter coli as neisseria cinerea with the vitek® 2 nh test kit (reference 21346).An investigation was performed.The customer reported setting up the strain from campylosel agar and incubating at 37°c in a microaerophilic environment for 24 hours.Campylosel agar is not a recommended agar for use with the nh card.One lab report was submitted showing a very good identification of n.Cinerea with three (3) atypical negative reactions (dmlt, pvate, lglm) for an identification of c.Coli according to the nh knowledge base.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Use of non recommended media may result in reactions which are not supported by the nh knowledge base.Without the strain or raw data, it's not possible to further evaluate the cause of the misidentification.The vitek 2 nh lot #2450361203 met final qc release criteria and passed 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; sant louis, MO 63042
• MDR Report Key: 6867918
• MDR Text Key: 86425933
• Report Number: 1950204-2017-00305
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: WZ
• 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: 03/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2018
• Device Model Number: 21346
• Device Lot Number: 2450361203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• 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