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

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 france reported a misidentification for an external quality control sample (ctcb 174-2) in association with the vitek® 2 anc test kit (lot 2440285403).Strain 174-2 is described in the ctcb report 174 as, "isolated bacteria from appendicular pus of a 9 years old child." the customer stated the anc card twice identified actinomyces odontolyticus at 94% and 95%, however, the expected result was eikenella corrodens.The customer reported using multiple aerobic, anaerobic and microaerophilic blood agars, and obtained growth in the aerobic and microaerophilic blood agar.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) reported a misidentification for an external quality control sample (ctcb 174-2) in association with the vitek® 2 anc test kit (lot 2440285403).An investigation was performed.The intended identification to eikenella corrodens was confirmed on vitek ms v3 (knowledge base v3.0).On vitek 2 (v7.01) anc cards, one card of the customer lot (440285403) and one card of a random lot (2440320203) were tested from cos subculture.These tests gave a result of "unidentified organism" with both lots tested, so it is not a misidentification, this result requires that a supplemental method should be performed.The vitek nh card tested in supplement (lot 2450288203), and an excellent identification to eikenella corrodens (97%) was obtained.In conclusion, the customer misidentification to actinomyces odontolyticus was not reproduced in-house.The intended species eikenella corrodens is not recommended on the anc card but on the nh card.The vitek anc card performed as intended and no further action is required.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC TEST KIT
• 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: 7269916
• MDR Text Key: 100255436
• Report Number: 1950204-2018-00071
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910666
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440285403
• Other Device ID Number: 03573026144364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1