MAUDE Adverse Event Report: BIOMERIEUEX, 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 cefepime (mic=2) result for an escherichia coli apr survey strain (ur-06, esbl phenotype)) in association with the vitek® 2 ast-gn73 test kit (lot 5930611403).Repeat testing also gave a susceptible result, when the expected result was resistant.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a customer in the united states that reported a false susceptible cefepime (fep) mic=2 result for an escherichia coli api survey strain (ur-06, esbl phenotype) in association with the vitek® 2 ast-gn73 test kit (lot 5930611403).The expected result for fep was resistant.The customer submitted their api ur-06 e.Coli survey strain for cefepime evaluation.The customer submitted 2 samples: ur06 "pellet" and ur06 "dilution".Identities for both were confirmed and testing was performed for both isolates on the customer lot and a random lot of ast-gn73 cards.Agar dilution (ad), the reference method for fep (fep02n) was also performed.For both isolates on all cards tested, fep mics<=1 (resistant) were obtained, with the susceptible result corrected to resistant by the aes software due to a proposed esbl phenotype.Agar dilution gave susceptible mics=8.Since card and reference method results are more than 1 doubling dilution apart, this is an essential agreement error for the vitek 2.The investigation concluded this is an atypical strain.

• Brand Name: VITEK® 2 AST-GN73 TEST KIT
• Common Device Name: VITEK® 2 AST-GN73 TEST KIT
• Manufacturer (Section D): BIOMERIEUEX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7818423
• Report Number: 1950204-2018-00297
• Device Sequence Number: 16728518
• Product Code: LON
• UDI-Device Identifier: 03573026398507
• UDI-Public: 03573026398507
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/30/2018

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: 11/18/2019
• Device Catalogue Number: 413404
• Device Lot Number: 5930722403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1