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

Catalog Number 21347

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 (b)(6) survey sample during proficiency testing, in association with the vitek® 2 anc test kit.The customer had a sample of an anaerobic gram negative rod and tested it twice, using two slightly different appearing colonies, and had an identification of bacteroides thetaiotaomicron (97%).The customer stated that api intended the organism identification to be bacteroides uniformis.The customer also pulled the back-up specimen, repeated the process, and again received the id of bacteroides thetaiotaomicron instead of bacteroides uniformis.The test reports and isolate have been requested from the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer from the united states reported to biomérieux a misidentification of an american proficiency institute (api) survey sample in association with the vitek® 2 anc test kit.An internal biomérieux investigation was performed.The organism was subbed on cba media and grown anaerobically for 48 hrs.Testing included two (2) customer lots and a random lot of anc cards.Vitek® ms and 16s sequencing was also performed.On all cards tested, a very good (95%) or excellent id (98%) of b.Thetaiotamicron was obtained.For testing on the vitek® ms, a 99.9% identity match of b.Thetaiotamicron was obtained.16s sequencing gave a 100% identity match to b.Thetaiotamicron.When the organism's 16s sequence was compared against the 16s sequence for b.Uniformis, there was only a 92% identity match.Therefore, the final identification is b.Thetaiotamicron.Vitek® 2 anc cards were determined to be performing as expected and no further action is necessary.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC 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: 6212426
• MDR Text Key: 63626083
• Report Number: 1950204-2016-00214
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910666
• 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: 02/27/2017

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: 11/18/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244399210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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