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)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states contacted biomérieux to report a discrepant organism identification for bacteroides ovatus atcc® baa-1296¿ in association with the vitek® 2 anc id test kit.The organism was reported as bacteroides stercoris, bacteroides eggerthii, low discrim prevotella oralis/bacteroides eggerthii, and prevotella oralis.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 atcc® strain.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the submitted pellet from customer stock # 585-34 (bacteroides ovatus atcc 1296) was rehydrated and along with the biomérieux internal quality control (qc) strain were subcultured to columbia blood agar (cba).Anc card testing included individual organism suspensions on cards from the two customer lots (2440560403, 2440541203) and a random lot (2440496103) in duplicate for each strain.911581 (585-34): five (5) of six (6) anc cards tested showed no qc deviations and no misidentifications were observed.For the remaining card, an atypical negative aara was demonstrated, but no misidentification was observed.400963 (biomérieux internal qc strain): no qc deviations or misidentifications were observed on any of the six (6) anc cards tested.One (1) of the customer's reported issues were duplicated with one atypical negative aara reaction on one (1) of six (6) anc cards tested with no misidentification and with the customer's strain only.Vitek® 2 cards performed as expected with the biomérieux internal qc 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: 7373423
• Report Number: 1950204-2018-00119
• Device Sequence Number: 1095093
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/06/2018

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: 06/09/2019
• Device Catalogue Number: 21347
• Device Lot Number: 2440560403
• 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: 03/04/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1