MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-GN69 TEST KIT

Catalog Number	413400
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 from the united states notified biomérieux of obtaining false resistant trimethoprim/sulfamethoxazole (sxt) when testing a patient strain of stenotrophomonas maltophilia, isolated from a urine sample, with the vitek® 2 ast-gn69 test kit (ref 413400).The customer repeated testing and received the same false resistant results.The customer sent out the strain to a reference lab, and they obtained a susceptible result.The customer reported that the patient was on antibiotics: cipro 500mg.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 has been initiated.
Additional Manufacturer Narrative
An internal investigation was performed for false resistant trimethoprim/sulfamethoxazole (sxt) results when testing a patient strain of stenotrophomonas maltophilia, isolated from a urine sample, with the vitek® 2 ast-gn69 test kit (ref 413400).The strain was submitted for investigation.The submitted strain was subcultured, and the identification was confirmed as s.Maltophilia.Testing included ast-gn69 cards from the customer's lot (5890790403) and a random lot (5890758403) as well as broth microdilution (bmd) as the reference method for sxt02n formulation on this card.911750: the ast-gn69 cards tested resulted in resistant sxt mics >/=320 and 80, while sxt bmd mic

• Brand Name: VITEK® 2 AST-GN69 TEST KIT
• Common Device Name: VITEK® 2 AST-GN69 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 8018955
• Report Number: 1950204-2018-00448
• Device Sequence Number: 1352646
• Product Code: LON
• UDI-Device Identifier: 03573026398460
• UDI-Public: 03573026398460
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K110106
• 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): 01/03/2019

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: 01/25/2020
• Device Catalogue Number: 413400
• Device Lot Number: 5890790403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1