MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN80 TEST KIT

Catalog Number	413437
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 an alcaligenes faecalis cap survey strain (d-08) in association with the vitek® 2 ast-gn80 test kit.The customer stated they had reported a resistant result.After learning the expected result was susceptible, the customer retested the sample and obtained a susceptible result.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a false resistant piperacillin/tazobactam result for an alcaligenes faecalis cap survey strain (d-08) in association with the vitek® 2 ast-gn80 test kit.The customer stated the reported result was resistant (mic >=128), and the repeat test was the expected susceptible result.The biomerieux internal cap d-08 survey strain was sub-cultured on tsab agar, identification confirmed as a.Faecalis ssp faecalis, and testing included multiple lots of multiple gn ast card types 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): on 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 () cards demonstrate an error for vitek 2 when compared to reference, duplicating the customers results.This is an atypical survey strain.

• Brand Name: VITEK® 2 AST-GN80 TEST KIT
• Common Device Name: VITEK® 2 AST-GN80 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7954386
• Report Number: 1950204-2018-00419
• Device Sequence Number: 1301716
• Product Code: LON
• UDI-Device Identifier: 03573026399023
• UDI-Public: 03573026399023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 09/13/2019
• Device Catalogue Number: 413437
• Device Lot Number: 6700656403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/10/2018
• 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