MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM POSITIVE (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 in the united states notified biomérieux of discrepant results associated with vitek® 2 gram positive (gp) test kit related to misidentification of an organism.The customer reported that they had a cap survey and the result was e.Casseliflavus three (3) times from three (3) different colonies when the expected organism was e.Gallinarum.Culture submittals were requested by biomérieux.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states had notified biomérieux of misidentification results for a cap survey when testing with vitek® 2 gram positive (gp) test kit; the vitek 2 result was enterococcus casseliflavus three (3) times from three (3) different colonies when the expected organism was enterococcus gallinarum.An internal biomérieux investigation was performed using the internal cap strain isolate.The internal cap reconstituted sample was subcultured and gp testing included individual organism suspensions on two cards from five different lots (including customer lot and random lot).The api 20 strep was also performed; although, it does not identify e.Casseliflavus or e.Gallinarum without supplemental testing.Nine (9) of the 10 gp cards tested resulted in low discrimination calls of e.Casseliflavus/e.Gallinarum.Vitek 2 proposed additional testing to separate these species.The isolate did not demonstrated yellow pigmentation and tested hip positive on the api test kit, resulting in an identification of e.Gallinarum.The remaining card gave an excellent identifications of e.Gallinarum.The vitek 2 gp cards were determined to be performing as expected.

• Brand Name: VITEK® 2 GRAM POSITIVE (GP) TEST KIT
• Type of Device: VITEK® 2 GRAM POSITIVE (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: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6267282
• MDR Text Key: 65468331
• Report Number: 1950204-2017-00024
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242390510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1