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

Catalog Number 21347

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event 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.

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
• Type of Device: VITEK® 2 ANC TEST CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7038388
• MDR Text Key: 93314407
• Report Number: 1950204-2017-00402
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440318203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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