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 Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of a misidentification associated with vitek® 2 gn test kit involving a patient sample.The customer reported the sample was taken from a toe and the vitek® 2 gn test kit identified the organism as citrobacter youngae.The second result was citrobacter amalonaticus (91%).As the indole was positive, they decided for citrobacter amalonaticus.In addition, the customer indicated the vitek® ms identified the organism as citrobacter freundii and enterobacter aerogenes.The second run was citrobacter freundii.They provided the final result as citrobacter amalonaticus.The customer indicated patient results were affected, the patient was not harmed or mistreated; however, there was a delay of greater than 24 hours.In addition, the customer indicated it was unknown as to whether an incorrect result was reported to the physician as the correct result was unknown at that time.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted due to a misidentification of citrobacter murliniae as citrobacter youngae or citrobacter amalonaticus in association with the vitek® 2 gn id test kit.An internal biomérieux investigation was performed.Investigational testing included: - 16s sequencing: obtained an identification to citrobacter murliniae.- vitek® 2 gn id (customer lot and random lot): both lots obtained a low discrimination between citrobacter youngae and citrobacter amalonaticus.Citrobacter murliniae is not in the vitek® 2 gn knowledge base.The vitek® 2 product information manual indicates which organisms can be identified using the vitek® 2 gn id card; citrobacter murliniae is not listed.The vitek® 2 gn id instructions for use (product information manual) state "newly described or rare species may not be included in the gn database.Selected species will be added as strains become available.Testing of unclaimed species may result in an unidentified result or a misidentification." for any organism placed into a test card, the vitek® 2 system will assess the card readings against the known organisms and provide an organism identification, if possible, based on a combination of growth well reactions.For results with a percent confidence of <99%, the customer must make a determination of acceptance or further testing based on the logical likelihood of the identification considering other laboratory and clinical factors.- vitek® ms: citrobacter werkmanii citrobacter murliniae is not in the vitek® ms knowledge base.- api® 50 che v3: after 24 hours citrobacter freundii 99,7% good identification; after 48 and 72 hours doubtul profile between citrobacter amalonaticus and pantoea spp 2 citrobacter murliniae is not in the api® knowledge base.The investigation concluded the vitek® 2 gn id test kit is performing as intended and as described in labeling.

• 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: 6121038
• MDR Text Key: 60691313
• Report Number: 1950204-2016-00191
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241385210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1