MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN66 TEST KIT

Catalog Number	413398
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a false resistant ertapenem for a proteus mirabilis patient urine sample using vitek® 2 ast-gn66 test kit in duplicate (reference #: 413398 lot# : 5861021103).The proteus mirabilis strain tested susceptible, and was then modified to resistant by the vitek 2 advanced expert system¿ (aes).The isolate was sent to a reference lab for testing and the results were susceptible.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint for a false resistant ertapenem result for a proteus mirabilis strain in association with the vitek® 2 ast-gn66 test kit.The customer strain was not submitted for investigational purposes.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Regarding the original complaint, mics obtained by vitek® 2 were as expected.The concern was regarding the therapeutic changes made by aes in response to proposal of the carbapenemase phenotype.Undesired therapeutic changes can be removed by the user, in a user-defined parameter set.Ast-gn66 lot #5861021103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-GN66 TEST KIT
• Common Device Name: VITEK® 2 AST-GN66 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8758385
• Report Number: 1950204-2019-00222
• Device Sequence Number: 19451119
• Product Code: LON
• UDI-Device Identifier: 03573026398446
• UDI-Public: 03573026398446
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K152075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2020
• Device Catalogue Number: 413398
• Device Lot Number: 5861021103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1