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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux a misidentification of api survey sample bacteroides unformis as bacteroides thetaiotaomicron, in association with the vitek®2 anc test kit.The customer repeated the test three times.Twice the results were 95% very good identification for b.Thetaiotaomicron and once a 99% excellent identification for b.Thetaiotaomicron.The customer confirmed that the isolates were cultured on the cdc medium.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

A customer from the united states reported to biomérieux a misidentification of api survey sample bacteroides unformis as bacteroides thetaiotaomicron, in association with the vitek® 2 anc test kit.An internal biomérieux investigation was performed.The organism was sub cultured 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; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6188570
• MDR Text Key: 62857896
• Report Number: 1950204-2016-00207
• 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: 01/27/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440062203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/20/2016
• 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