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

Model Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer in the united states notified biomérieux of discrepant results associated with vitek® 2 gp test kit ((b)(4)).The customer reported that two (2) isolates of the blood cultures were reported in error.The gp lot number 2420331403 gave a result of listeria innocua.The test results were run twice, once with each culture, repeat testing was not performed.Csf yielded listeria monocytogenes on gp lot number 24202092303.The isolates from the blood cultures were repeated and give an identification of listeria monocytogenes.Blood culture isolate was set to the state health laboratory and the customer is still waiting for results.The physician treated the patient with penicillin due to the initial result.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states notified biomérieux of discrepant results associated with vitek® 2 gp test kit (reference 21342).The customer submitted three (3) strains for evaluation.An investigation was performed.The three (3) submitted strains were subcultured and tested on vitek® 2 gp cards, which included two (2) cards from each of the two (2) customer lots (24200331403, 2420209203) ,and one (1) card from a random lot.(2420303403), totaling five (5) cards for each isolate.An excellent identification of listeria monocytogenes was the result for all three (3) isolates on the fifteen (15) gp cards tested.The three (3) isolates were also tested with vitek® ms which resulted in an identification of listeria monocytogenes (99.9%) for all three (3) isolates.A review of the customer's listeria innocua results against expected reactions for listeria monocytogenes revealed one atypical negative reaction (piplc) according to the gp knowledgebase, contributing to the misidentification.Note: in the vitek® 2software version 8.01, all identifications of listeria innocua will display a note stating possibility of listeria monocytogenes, check for beta hemolysis in conclusion, the vitek® 2 gp test kit performed as expected.

• 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; saint louis, MO 63042
• MDR Report Key: 6854639
• MDR Text Key: 85625719
• Report Number: 1950204-2017-00297
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2018
• Device Model Number: 21342
• Device Lot Number: 2420331403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2017
• 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
• Patient Outcome(s): Other