MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT; VITEK® 2 NH ID TEST KIT

Catalog Number	21346
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
A customer in (b)(6) contacted biomérieux to report a misidentification of capnocytophaga species (quality control sample) in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.Five vitek® 2 nh id (5) tests were performed simultaneously from the same isolate; all five tests provided a result of low discrimination between neisseria and moraxella species.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.The quality control sample was not directly associated with any patient.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation has been initiated.
Additional Manufacturer Narrative
A customer in (b)(6) contacted biomérieux to report a misidentification of capnocytophaga species (quality control sample) in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.An internal biomérieux investigation was performed.The intended identification to capnocytophaga carnimorsus was confirmed on vitek® ms v3 (knowledge base v3.0).On vitek® 2 (v7.01) nh cards, two (2) cards of the customer lot (cl : 2450285403) from cba subculture and two (2) cards of a random lot (rl : 2450288203) from pvx subculture were tested.These tests on the cl gave a very good identification to neisseria elongata 94% from cba subcultures and a good identification to neisseria gonorrhoeae 89% from pvx subcultures.On the rl, unidentified results were obtained from both subcultures.The customer misidentification was reproduced on the customer lot #2450285403 whatever the media used while the random lot #2450288203 gave no identification.Vitek® 2 nh test kit lot #2450285403 met final qc release criteria.This lot passed qc performance testing.This is an atypical strain.

• Brand Name: VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT
• Common Device Name: VITEK® 2 NH ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 6793974
• Report Number: 1950204-2017-00268
• Device Sequence Number: 1760900
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: CL. I 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): 12/04/2017

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: 09/07/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450285403
• 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: 07/24/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1