MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN83 TEST KIT

Catalog Number	413440
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 notified biomérieux of false resistant results for cap survey strain (d-08) when testing with the vitek® 2 ast-gn83 test kit.The alcaligenes faecalis strain tested false resistant (mic >=128) for piperacillin/tazobactam using gn83 lot 6730703103.The expected result is susceptible.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 has been initiated.
Additional Manufacturer Narrative
A customer in the united states notified biomérieux of false resistant results for cap survey strain (d-08) when testing with the vitek 2 ast-gn83 cards.The alcaligenes faecalis ssp faecalis strain resulted in resistant mics >/= 128 for piperacillin/tazobactam (tzp).The expected result was susceptible.The customer submitted their strain for investigation.The customer's submitted strain and the biomerieux cap d-08 survey strains were subcultured on tsab agar, and identifications were confirmed as a.Faecalis ssp faecalis.Testing included ast-gn83 cards from a customer lot (6730703103) and a random lot (6730624203) as well as broth microdilution (bmd) as the reference method for tzp03n formulation on this card.911727 (customer's d-08 strain): on the customer lot of ast-gn83 cards, an intermediate mic=64 was obtained and on the random lot a resistant mic >/= 128 was obtained.Bmd gave a susceptible mic /= 128.Bmd gave a susceptible mic

• Brand Name: VITEK® 2 AST-GN83 TEST KIT
• Common Device Name: VITEK® 2 AST-GN83 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7878534
• Report Number: 1950204-2018-00365
• Device Sequence Number: 2061108
• Product Code: LON
• UDI-Device Identifier: 03573026399054
• UDI-Public: 03573026399054
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/14/2018

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: 10/30/2019
• Device Catalogue Number: 413440
• Device Lot Number: 6730703103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/14/2018
• 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