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 false resistant piperaciliin/tazobactum results for an alcaligenes faecalis cap survey strain (d-08), in association with the vitek® 2 ast-gn69 test kit (lot 5890692203).The customer tested the strain from bbl macconkey media (validated) and reported that the a.Faecalis strain was piperaciliin/tazobactum resistant (mic >=128).The expected cap survey result was susceptible.The customer then performed repeat testing with the ast-n69 card and the result was susceptible (mic <=4).Testing with microscan gave a susceptible result (mic<=16).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 5890692203 and obtained a tzp mic>=128.Upon repeat testing, the result was susceptible (mic<=4).Additionally, the organism was tested on microscan walkaway, where a susceptible mic<=16 was obtained.Biomérieux internal investigation was conducted.The customer's cap d-08 strain and the internal biomerieux cap d-08 survey strain were sub-cultured on tsab media and identification to alcaligenes faecalis ssp faecalis was confirmed.Testing was performed on the customer lot and a random lot of ast-gn69 cards.Broth microdilution (bmd), the reference method for tzp (tzp03n) development, was also performed.911735 (customer's d-08 strain): on the customer lot of ast-gn69 cards, an intermediate mic=64 was obtained, on the random lot, a susceptible mic<=4 was obtained.Bmd gave a susceptible mic<=4.Card and reference method are in agreement for the random lot, but the customer lot result is a minor category error when compared to reference method.911704 (internal d-08 strain): on the customer lot of ast-gn69 cards, an intermediate mic=64 was obtained, on the random lot, a susceptible mic<=4 was obtained.Bmd gave a susceptible mic<=4.Card and reference method are in agreement for the random lot, but the customer lot result is a minor category error when compared to reference method.The investigation concluded the cap d-08 2018 strain to be an atypical strain.

• 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: 7890679
• Report Number: 1950204-2018-00377
• Device Sequence Number: 2726254
• Product Code: LON
• UDI-Device Identifier: 03573026398460
• UDI-Public: 03573026398460
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: 10/19/2019
• Device Catalogue Number: 413400
• Device Lot Number: 5890692203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/19/2018
• 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