MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN73 TEST KIT

Catalog Number	413404
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 in the united states reported a false susceptible ampicillin/sulbactam result for an escherichia coli esbl positive api survey strain, in association with the vitek® 2 ast-gn73 test kit (lot 5930713203).The customer twice obtained a susceptible result (mic=8) for ampicillin/sulbactam.The expected result for this survey strain was intermediate/resistant.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
The customer no longer has their api survey strain for this investigation.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.Vitek 2 ast-gn73 lot# 5930713203 met final qc release criteria and passed qc performance testing.

• Brand Name: VITEK® 2 AST-GN73 TEST KIT
• Common Device Name: VITEK® 2 AST-GN73 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7836983
• Report Number: 1950204-2018-00316
• Device Sequence Number: 1809058
• Product Code: LON
• UDI-Device Identifier: 03573026398507
• UDI-Public: 03573026398507
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N50510: S 97
• 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): 11/28/2018

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: 11/09/2019
• Device Catalogue Number: 413404
• Device Lot Number: 5930713203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1