MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GP ID TEST KIT; VITEK® 2 GP ID 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 twice misidentified enterooccus gallinarum cap survey sample, as enterococcus casseliflavus (99%) in association with vitek® 2 gp id test kit.The results were not reported to a physician as there was no patient directly associated with the survey sample.The test report, survey results, and isolate will be submitted by the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A biomérieux internal investigation was conducted for a twice misidentified enterooccus gallinarum cap survey sample, as enterococcus casseliflavus (99%) in association with vitek® 2 gp id test kit.The customer and the reconstituted internal cap strains were subcultured to individual organism suspensions and each was tested with two gp cards from the customer lot and a random lot.The api 20 strep was also performed.For the customer's cap strain, three of the four gp cards tested resulted in low discrimination calls of e.Casseliflavus/e.Gallinarum.The remaining card gave an excellent identification of enterococcus gallinarum.For the internal cap strain, three of the four gp cards tested resulted in low discrimination calls of e.Casseliflavus/e.Gallinarum.The remaining card gave an excellent identification of enterococcus gallinarum.Neither of the two isolates demonstrated yellow pigmentation and both tested hip positive on the api 20 strep test kit, resulting in an identification of e.Gallinarum.The investigation concluded the vitek® 2 gp id cards are performing as expected.

• Brand Name: VITEK® 2 GP ID TEST KIT
• Type of Device: VITEK® 2 GP ID 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: 6289480
• MDR Text Key: 66151597
• Report Number: 1950204-2017-00037
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420063403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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