MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN67 TEST KIT

Catalog Number	413399
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 discrepant susceptibility results for cap survey strain(d-08), alcaligenes faecalis, when testing with the vitek® 2 ast-gn67 test kit.On initial and repeat testing, the strain tested false resistant (mic >128) for piperacillin/tazobactam.The expected result for this ungraded survey strain 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 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 the vitek® 2 ast-gn67 test kit, lot 5870681203 and obtained a tzp mic>=128.Biomérieux internal investigation was conducted.For this investigation, the biomerieux internal 2018 cap d-08 strain was tested.The biomerieux cap d-08 survey strain was sub-cultured on tsab agar, identification confirmed as a.Faecalis ssp faecalis, and testing included ast-gn95 (6850485403), ast-gn67 (5870659203), ast-gn69 (5890711103) card lots in duplicate 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): - for the 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 (3) cards demonstrated a major error for vitek 2 when compared to reference, duplicating the customers results.This investigation concluded the cap strain to be atypical.The strain will be added to the r&d stock collection.

• Brand Name: VITEK® 2 AST-GN67 TEST KIT
• Common Device Name: VITEK® 2 AST-GN67 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7986474
• Report Number: 1950204-2018-00442
• Device Sequence Number: 16492780
• Product Code: LON
• UDI-Device Identifier: 03573026398453
• UDI-Public: 03573026398453
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 10/08/2019
• Device Catalogue Number: 413399
• Device Lot Number: 5870681203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/19/2018
• 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