MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-GN77; VITEK® 2 AST-GN77

Catalog Number	413434
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from the united states contacted biomérieux to report a false susceptible cefepime (mic = 2) result for an api survey sample (ur-06 escherichia coli) in association with the vitek® ast-gn77 test kit.The expected result for the survey was cefepime resistant.The customer no longer has the api strain in their possession.There is no indication or report from the laboratory or a physician that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the api survey strain.Biomérieux requested strain submittal from the customer; however, the strain is no longer available.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated after a customer reported testing api proficiency survey ur-06 escherichia coli and obtaining a susceptible result for cefepime (mic=2) using the vitek® 2 ast-gn77 test kit, lot 5970607103.The expected result for the survey is resistant.The customer did not keep the strain for investigation.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to reference method.Vitek 2 ast-gn77 lot # 5970607103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-GN77
• Common Device Name: VITEK® 2 AST-GN77
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7957990
• Report Number: 1950204-2018-00424
• Device Sequence Number: 16482685
• Product Code: LON
• UDI-Device Identifier: 03573026398996
• UDI-Public: 03573026398996
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161227
• 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): 12/19/2018

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: 07/26/2019
• Device Catalogue Number: 413434
• Device Lot Number: 5970607103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1