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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported a false resistant piperacillin/tazobactam result for a alcaligenes faecalis (b)(4) strain in association with the vitek® 2 ast-gn69 test kit.The alcaligenes faecalis strain tested resistant (mic >=128) and the expected result was susceptible.The customer repeated testing on a different lot and the result was resistant.The customer stated that they obtained a susceptible result with disk diffusion.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A united states customer submitted their cap d-08 2018 alcaligenes faecalis ssp faecalis strain for piperacillin/tazobactam (tzp) evaluation because the customer reported resistant tzp results, but the expected result was susceptible.The customer originally tested the organism on vitek® 2 ast-gn69 lot 5890711103 and obtained a tzp mic>=128.Biomérieux internal investigation was conducted.For this investigation, the biomerieux internal 2018 cap d-08 strain was tested.The biomerieux cap d-08 survey strain was sub-cultured on tsab agar, identification confirmed as a.Faecalis ssp faecalis, and testing included ast-gn95 (6850485403), ast-gn67 (5870659203), ast-gn69 (5890711103) card lots in duplicate as well as broth microdilution (bmd) as the reference method for tzp03n formulation found on all card types associated with this investigation.911704 (biomerieux internal d-08 strain): - for the ast gn cards tested, susceptible mic <= 4, intermediate mic = 64 and resistant mics => 128 were all obtained.- bmd gave a susceptible mic <= 4.- card and reference method are in agreement for three (3) of six (6) cards tested while the remaining three (3) cards demonstrated a major error for vitek 2 when compared to reference, duplicating the customers results.This investigation concluded the cap strain to be atypical.The strain will be added to the r&d stock collection.

• 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; hazelwood MO 63042
• MDR Report Key: 7925707
• Report Number: 1950204-2018-00402
• Device Sequence Number: 19311415
• Product Code: LON
• UDI-Device Identifier: 03573026398460
• UDI-Public: 03573026398460
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K113200
• 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): 11/16/2018

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: 11/07/2019
• Device Catalogue Number: 413400
• Device Lot Number: 5890711103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1