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 with vitek® 2 nh test kit.The customer reported that the nh card identified the bacterium campylobacter coli, but using another testing method api campy resulted in campylobacter jejuni.The customer reported that c.Jejuni is likely the correct results because hippurate hydrolase test result was positive.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
This report was initially submitted following notification from a customer in (b)(6) of discrepant results associated with vitek® 2 nh id test kit.The customer reported that the nh id card identified the bacterium campylobacter coli, but using another testing method (api campy) resulted in campylobacter jejuni.Internal investigation was conducted.The customer submitted a campylobacter jejuni survey isolate (2017-06 survey 33).The submitted isolate was subcultured and incubated in microaerophilic conditions at 42° c.Testing included individual organism suspensions on nh id cards from the customer's lot and a random lot.Vitek® ms testing was also performed.A total of eight nh id cards were tested, all resulting in very good identifications of neisseria cinerea.Vitek® ms resulted in the expected identification of campylobacter jejuni with a 99.9 % confidence value.A review of the customer's data against expected reactions for identification of campylobacter jejuni demonstrated four atypical negative reactions (pyra, pvate, dmlt, ops) contributing to the misidentifications.A review of the internal neisseria cinerea data against expected reactions for identification of campylobacter jejuni demonstrated six atypical negative reactions (pyra, pvate, dmlt, ops, odc and iglm) contributing to the misidentifications.Only one reaction was positive on internal testing (leua) suggesting possible strain viability issues with extended transportation.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.The investigation concluded the customer submittal is an atypical organism strain.

• 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: 6718040
• Report Number: 1950204-2017-00217
• Device Sequence Number: 998908
• 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): 10/16/2017

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: 01/13/2018
• Device Model Number: 21346
• Device Lot Number: 2450048203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1