MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GP TEST KIT

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of discrepant results associated with vitek® 2 gp test kit (reference (b)(4)).The customer reported testing listeria monocytogenes and received a result of listeria inocua on a patient sample.The customer stated they didn't perform b-hemolysis offline testing to verify yet.Customer stated they grew the organism at 35c on tsa w/ blood for 18-24 hours, using remel media.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states notified biomérieux a misidentification of listeria monocytogenes and received a result of listeria inocua associated with vitek® 2 gp test kit (reference 21342).An investigation was performed.A review of quality records confirmed vitek 2 gp lot # 2420200103 met final qc release criteria and passed initial qc performance testing.No information was provided by the customer concerning their set up or reference methods.Since a lab report was not provided, no analysis of atypical reactions can be performed.Without the strain, raw data or lab reports it's not possible to further evaluate the cause of the misidentification.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 7104834
• MDR Text Key: 95757462
• Report Number: 1950204-2017-00444
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C 1 EXEMPT
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420200103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1