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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the united states food industry reported to biomérieux a misidentification when testing a bioball in association with the vitek® 2 gp test kit.The customer reported that they were testing a known listeria monocytogenes strain (421372 lot b3824) from a bioball with the vitek 2 , and the result was listeria innocua / monocytogenes.The organism was hemolytic on the agar prior to testing.The customer stated that they also tested the organism several times on the vitek ms and the result was l.Monocytogenes each time.There was no patient involvement as the event pertained to food industry testing.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the united states food industry reported to biomérieux a misidentification when testing a bioball in association with the vitek® 2 gp test kit.The customer reported that they were testing a known listeria monocytogenes strain (421372 lot b3824) from a bioball with the vitek 2 , and the result was listeria innocua / monocytogenes.The organism was hemolytic on the agar prior to testing.The customer stated that they also tested the organism several times on the vitek ms and the result was l.Monocytogenes each time.An internal biomérieux investigation was performed.No information was provided concerning the customer's set up procedure.Nineteen (19) lab reports were submitted.- two (2) lab reports showed excellent identification of l.Monocytogenes.- twelve (12) lab reports showed a low discrimination identification between l.Monocytogenes and l.Innocua, which is considered a correct identification.- five (5) lab reports showed an excellent identification of l.Innocua with one (1) atypical negative reaction (piplc) for an identification of l.Monocytogenes according to the gp knowledge base.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up error, or an atypical strain.However, without the strain or raw data, it is not possible to further evaluate the cause of the misidentification.Vitek 2 gp id lot 2420393403 met final quality control (qc) release criteria and passed qc performance testing.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7171631
• MDR Text Key: 97678346
• Report Number: 1950204-2018-00010
• Device Sequence Number: 1
• Product Code: LQL
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420393403
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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