MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANC TEST KIT; VITEK® 2 ANC TEST CARD

Catalog Number	21347
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of misidentification results for bacteroides fragilis (b)(4) strain in association with vitek® 2 anc test kit (ref 21347).The strain was tested three times with vitek® 2, which provided the following identifications: first test: bacteroides stercoris 95%.Second test: prevotella bivia 95%.Third test: bacteroides stercoris 95%.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 associated with this qc strain.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
A customer in (b)(6) had notified biomérieux of misidentification results for bacteroides fragilis atcc25285 strain in association with vitek® 2 anc test kit (ref 21347).The strain was tested three times with vitek® 2, which provided the following identifications: first test: bacteroides stercoris 95%.Second test: prevotella bivia 95%.Third test: bacteroides stercoris 95%.An internal biomérieux investigation was completed.The intended identification of bacteroides fragilis was confirmed on vitek ms v3 (knowledge base v3.0).On vitek 2 (v7.01) anc cards, one (1) card of the customer lot (cl : 2440318203) and one (1) card of a random lot (rl : 2440320203) were tested from cba subculture.These tests gave an excellent identification to b.Fragilis on both lots.The customer misidentification was not duplicated in-house.The vitek 2 anc card performed as intended.

• Brand Name: VITEK® 2 ANC TEST KIT
• Common Device Name: VITEK® 2 ANC TEST CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7038388
• Report Number: 1950204-2017-00402
• Device Sequence Number: 1109342
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K910666
• 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): 02/06/2018

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: 10/10/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440318203
• 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: 10/23/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1