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

Catalog Number 21341

Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification associated with the vitek 2 gn test kit. The customer reported the vitek 2 gn test kit gave inadequate results of serratia fonticola instead of escherichia coli. The customer indicated performing a biochemical manual test as the alternate testing for identification. The customer indicated e. Coli results were reported out. An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An investigation was conducted for a misidentification of escherichia coli as serratia fonticola in association with the vitek® 2 gn test kit. Information showed the customer was having identification issues with multiple species. Troubleshooting indicated that the customer prepared their own media, their saline may have been contaminated, and they did not test isolates at the appropriate age of culture. After the customer used prepared media from biomerieux, sterile saline, and an appropriate age of culture, all the identification issues ceased. Two lab reports were submitted for review. One lab report showed an excellent identification of serratia fonticola. There were four (4) atypical positive reactions (ado, ple, sac, dtag) against identification of e. Coli according to the gn knowledge base. The second lab report showed an excellent identification of e. Coli. A review of quality records confirmed gn lot 241390240 met final release criteria and there were no issues with initial performance testing an increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain. However without the strain, or raw data it's not possible to further evaluate the cause of the 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6120952
• MDR Text Key: 60878253
• Report Number: 1950204-2016-00190
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/24/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241375320
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial