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

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of a misidentification for a begeyella zoohelcum external quality control sample (ctcb 164-2), as myroides or brevundimonas, in association with the vitek® 2 gn test kit.The expected result was begeyella zoohelcum, however, the initial and repeat test results were myroides and brevundimonas, respectively.The sample was cultured on cos and gts media.The test reports were requested from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed.The investigation was initiated due to a misidentification of bergeyella zoohelcum on (b)(4) survey ((b)(4)), as myroides spp.(b)(4) information: identification to the species for 63.4% of participants and to the genus for 64.4%.The isolate was subcultured on columbia blood agar medium, and testing included vitek® 2 gn cards from the customer lot (cl:241389540) & random lot (rl: 241379810).The results were compared with sequencing full 16s used to determine the intended result.The reference method confirmed the identification to the species bergeyella zoohelcum.On vitek® 2, multiple lots of gn cards gave a low discrimination call of myroides spp/ brevundimonas diminuta/vesicularis.The misidentification to the species myroides spp obtained by the customer (low discrimination in house) was not reproduced.Bergeyella zoohelcum is not in the vitek® 2 knowledge base (kb) and there is a limitation for species not claimed in the kb: testing of unclaimed species may result in an unidentified result or a misidentification.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 2 GN 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: 6383796
• MDR Text Key: 69276328
• Report Number: 1950204-2017-00080
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C1, EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241391440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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