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

Model 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 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.
Additional 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
• Common Device Name: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 6867918
• Report Number: 1950204-2017-00305
• Device Sequence Number: 16316519
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2018
• Device Model 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: 08/18/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1