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 results for a cap survey strain (d-08) when testing with the vitek® 2 ast-gn95 test kit.The alcaligenes faecalis strain tested false resistant (mic >=128) for piperacillin/tazobactam using the ast-gn95 card, lot 6850485403.The expected result is susceptible.The customer did repeat testing and still obtained resistant results (mic >/=128) with the same lot.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 investigation was performed for false resistant (mic >=128) piperacillin/tazobactam results for a alcaligenes faecalis cap survey strain (d-08) when testing with the vitek® 2 ast-gn95 test kit.The biomerieux cap d-08 survey strain was subcultured on tsab agar, and the identification was confirmed as a.Faecalis ssp faecalis.Testing included the ast-gn95 (6850485403) card lot 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): the ast-gn95 card was susceptible mic [

• 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: 7893634
• Report Number: 1950204-2018-00382
• Device Sequence Number: 1395006
• 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: 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): 11/13/2018

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: 10/23/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1