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

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of klebsiella pneumoniae as klebsiella oxytoca (99%) in association with the vitek® 2 gn test kit.The isolate was tested with the filmarray® and was identified as klebsiella pneumonia, while testing with the vitek®2 gn identified klebsiella oxytoca.The customer reported there was no impact to the patient.The isolate was requested from the customer.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

An internal biomérieux investigation concluded the following: the submitted isolate was subcultured and testing included gn cards from the customer's lot and a random lot, in duplicate.Also tested was the api 20e test kit.All four gn cards tested resulted in excellent identifications of klebsiella pneumoniae.The api 20e gave a low discrimination identification of k.Pneumoniae 1/ k.Pneumoniae 2.Vitek 2 gn cards are performing as expected.A review of the customer's k.Oxytoca data (analysis time of 2 hours) against the expected reactions for k.Pneumoniae demonstrated 1 atypical positive reaction (iarl) contributing to 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6230884
• MDR Text Key: 64128846
• Report Number: 1950204-2017-00005
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: C1, 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241385810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1