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

Catalog Number 21347

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2017

Event Type  malfunction  

Event 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.

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
• Type of Device: VITEK® 2 ANC ID CARD
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7292527
• MDR Text Key: 101148144
• Report Number: 1950204-2018-00085
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Catalogue Number: 21347
• Device Lot Number: 2440422103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2017
• 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