MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN67 TEST KIT

Catalog Number	413399
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 (mic=8 s) for an api survey strain (escherichia coli, esbl) in association with the vitek® 2 ast-gn67 test kit.The expected result was resistant.The customer did repeat the test and the result was the same.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a customer in the united states who reported a false susceptible ampicillin/sulbactam result (mic=8 s) for an api survey strain (escherichia coli, esbl) in association with the vitek® 2 ast-gn67 test kit.The expected result for ams was resistant.The customer submitted their api e.Coli survey strain ur-06 for ampicillin/sulbactam (ams) evaluation.The strain identification was confirmed, and testing included both the customer lot and a random lot of ast-gn67 cards.Agar dilution (ad), the reference method for ams, was also performed.On the customer lot of ast-gn67 cards, a susceptible ams mic=4 was obtained, and, on the random lot, an intermediate mic=16 was obtained.Ad gave an intermediate mic=16.The random card lot is in agreement with the reference method results; however, the customer lot results are more than 1 doubling dilution from the reference method, which is an essential agreement and minor category error for the vitek 2.Investigation concluded this is an atypical strain.

• Brand Name: VITEK® 2 AST-GN67 TEST KIT
• Common Device Name: VITEK® 2 AST-GN67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7810466
• Report Number: 1950204-2018-00295
• Device Sequence Number: 1510718
• Product Code: LON
• UDI-Device Identifier: 03573026398453
• UDI-Public: 03573026398453
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: S50510: 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): 11/02/2018

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: 413399
• Device Lot Number: 5870607403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1