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 in association with vitek® 2 gp test kit.Repeat testing resulted in the same misidentification.The customer reported the organism was subcultured three (3) times before testing.There was no patient involvement as the isolate was a survey sample.The test reports were requested from the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

A customer from the united states had notified biomérieux of a misidentification of an enterococcus gallinarum, external quality control (cap) survey sample in association with vitek® 2 gp test kit.Vitek 2 identified the organism as enterococcus casseliflavus.Repeat testing resulted in the same misidentification.An internal biomérieux investigation was performed using the internal cap strain.The internal cap reconstituted sample was subcultured and gp testing included individual organism suspensions on two cards from five different lots(including customer 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 identification of e.Gallinarum.The vitek 2 gp cards were determined to be performing as expected.

• 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: 6292342
• MDR Text Key: 66510514
• Report Number: 1950204-2017-00039
• 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,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420099103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2016
• 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