MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KIT; VITEK® 2 ANC ID CARD

Catalog Number	21347
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from the united states contacted biomérieux to report the occurrence of a misidentification of eggerthella lenta ((b)(6)) as actinomyces odontolyticus in association with the vitek® 2 anaerobic and corynebacteria (anc) id test kit.The customer reported the result to (b)(6) as actinomyces species.Upon receiving the (b)(6) report indicating eggerthella lenta, repeat testing was performed and obtained eggerthia catenaformis.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.There was no patient directly associated with the (b)(6) strain.Culture submittal was requested by biomérieux to be available for internal investigation; however, the customer stated it was likely no longer viable.Biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the biomérieux internal cap d-17 swab was re-hydrated and subcultured to remel anaerobic blood agar.Testing included individual organism suspensions with anc cards from two different card lots as well as the vitek® ms instrument.The anc cards resulted in low discrimination identifications of e.Lenta/clostridium group.The vitek® ms instrument identified the isolate as e.Lenta with a 99.9% confidence value.Vitek® 2 anc cards are performing as expected.A review of the customer's actinomyces odontolyticus reactions demonstrated five (5) atypical positive reactions (leua, phea, tyra, appa, phos) and one (1) atypical negative reaction (arg) for an identification of e.Lenta according to the anc knowledge base.A review of the customer's e.Catenaformis reactions only demonstrated one atypical reaction as the offline testing indicated the isolate to be aerobic instead of anaerobic for an identification of e.Lenta according to the anc knowledge base.An increased number of atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non- recommended media or other user set up errors or an atypical strain.

• Brand Name: VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KIT
• Common Device Name: VITEK® 2 ANC ID CARD
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7292527
• Report Number: 1950204-2018-00085
• Device Sequence Number: 19093667
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K910666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 01/22/2019
• Device Catalogue Number: 21347
• Device Lot Number: 2440422103
• 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: 01/31/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1