MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN95 TEST KIT

Catalog Number	421982
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 notified biomérieux of false resistant ceftriaxone results obtained on a cap survey strain (citrobacter braakii) when testing with the vitek® 2 ast-gn95 test kit, lot 6850485403.The resistant ceftriaxone result was obtained with initial and repeat testing.The expected result was susceptible.When the customer received the survey results, she tested with microscan and obtained susceptible results.The customer did repeat testing on (b)(6) 2018 and obtained a susceptible result.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed for false resistant ceftriaxone (ctr) results obtained twice (mics = 32 and 8) with cap 2018 d-12 survey strain, citrobacter braakii, when testing with the vitek® 2 ast-gn95 test kit, lot 6850485403.The internal biomérieux cap 2018 d-12 strain was re-hydrated, subcultured to tsab and demonstrated two (2) distinct colony morphologies.The colonies were isolated, and the identifications were confirmed as c.Braakii.Testing included vitek ast-gn95 cards from the customer's lot (6850485403) in duplicate, as well as broth microdilution (bmd) as the reference method for cro02n formulation found in this card, for both strains.Only two (2) lots of vitek 2 gn95 cards were manufactured to date and the second lot (random lot) was not available for this investigation.Test results on strain 911785 and 911786 (biomérieux internal cap strains): all four (4) vitek 2 gn95 cards resulted in susceptible ceftriaxone mics

• Brand Name: VITEK® 2 AST-GN95 TEST KIT
• Common Device Name: VITEK® 2 AST-GN95 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7893636
• Report Number: 1950204-2018-00383
• Device Sequence Number: 13841007
• Product Code: LON
• UDI-Device Identifier: 03573026565923
• UDI-Public: 03573026565923
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161217
• 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): 12/05/2018

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: 03/26/2019
• Device Catalogue Number: 421982
• Device Lot Number: 6850485403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1