MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE ID TEST KIT; VITEK® 2 GP ID TEST KIT

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of misidentification results for a quality control listeria monocytogenes strain when testing with the vitek® 2 gp id test kit (ref.(b)(4)).Initially, vitek 2 obtained a low discrimination result which included listeria monocytogenes as a result.But on repeat testing, vitek 2 identified the listeria monocytogenes atcc 19115 strain as listeria welshimeri.As there was no patient directly associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed due to a customer who obtained misidentifications for listeria monocytogenes atcc® 19115¿ when testing with vitek® 2 gp test kit.The customer obtained a good identification of listeria welshimeri or a low discrimination l.Monocytogenes/l.Welshimeri.The customer's isolate was submitted for the investigation.The organism was subbed and tested on both the customer lot and a random lot of gp cards, in duplicate.Vitek ms was also performed.The organism was tested on both the customer lot and a random lot of vitek 2 gp cards, in duplicate.Testing with vitek ms was also performed.On all four (4) cards, an excellent identification (99%) of l.Monocytogenes was obtained.When tested on vitek ms, an identification of l.Monocytogenes was also obtained with a 93.6% confidence level.A comparison of the customer card reaction results against expected results for l.Monocytogenes revealed three (3) atypical positive reactions (dxyl, draf, sac) and one (1) atypical reaction (piplc), which led to the misidentification.An increased number of atypical reactions can indicate contamination, mixed culture, reduced strain viability, use of non-recommended media or other user set up errors.The customer's misidentification was not reproduced.Vitek 2 gp id cards performed as expected, and no further action is necessary.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Type of Device: VITEK® 2 GP ID 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7442905
• MDR Text Key: 106738363
• Report Number: 1950204-2018-00148
• 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: C1 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420510103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• 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