MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GP TEST KIT; VITEK® 2 GP TEST CARD

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 reported to biomérieux a misidentification of an external quality control (cap) survey sample of enterococcus gallinarum, as enterococcus casseliflavus (97%) in association with vitek 2 gp test kit.Repeat testing produced a result of low discrimination with an identification of enterococcus gallinarum.The test reports were requested from the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in the united states reported the occurrence of a misidentification of enterococcus gallinarum as enterococcus casseliflavus in association with the vitek® 2 gram-positive (gp) identification (id) test kit (card).Biomérieux investigation was conducted; however, the customer did not comply with the request for isolate submittal or raw data.The internal lyophilized cap sample was reconstituted and tested.The reconstituted sample was sub-cultured and vitek® 2 gp id testing included two cards each from four customer lots and two cards from a random lot (10 gp id cards in total).Nine (9) of the ten (10) gp id cards tested resulted in low discrimination calls of enterocccus casseliflavus / enterococcus gallinarum.Vitek® 2 proposed additional testing to separate these species.The remaining card gave an excellent identifications of enterococcus gallinarum.Api® 20 strep was also performed although it does not identify enterococcus casseliflavus or enterococcus gallinarum without supplemental testing.The isolate did not demonstrate yellow pigmentation and tested hip positive on the api® test kit, resulting in an identification of enterococcus gallinarum.The investigation concluded the vitek® 2 gp id test kits are performing as intended.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST CARD
• 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 ; 3147317301
• MDR Report Key: 6247257
• MDR Text Key: 64735346
• Report Number: 1950204-2017-00014
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242388440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1