MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-GN70 TEST KIT

Catalog Number	413401
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported false susceptible ertapenem results for two klebsiella pneumoniae strains from one patient, in association with the vitek® 2 ast-gn70 test kit (lot 5900705403).The customer reported that the ertapenem was susceptible with initial testing (mic= <=0.5).Upon repeat testing ertapenem tested resistant (mic=2 with new lowered carbapenem breakpoints).Ertapenem disc testing was resistant with zone size of 15 mm.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A biomérieux internal investigation was performed for the reported false susceptible ertapenem (etp) results for two klebsiella pneumoniae strains from one patient, in association with the vitek® 2 ast-gn70 test kit (lot 5900705403).The customer's two submitted strains were subcultured, and identifications of klebsiella pneumoniae were confirmed.Testing included ast-gn70 cards from the customer lot (5900705403) and a random lot (5900650403) ,as well as agar dilution (ad) as the reference method for the etp01n formulation used in this card.Etp breakpoints: /=2 (r).Strain 911676 (k.Pneumoniae #1): for one card etp mics = 1 with aes modification to resistant due to impermeability carbapenemase phenotype detected.This card is an essential agreement error with the reference with a minor error of category.For the second card etp mic = 2.Etp (same phenotype detected).Etp reference ad mic = 4.This card is in essential agreement with the reference method.Strain 911677 (k.Pneumoniae #2): both cards tested resulted in etp mic = 2 with the same impermeability carbapenemase phenotype detected.Etp reference ad mic = 4.Vitek 2 cards and reference method are in essential agreement.The customer's reported false susceptibility was not duplicated.Vitek 2 cards are performing as expected.

• Brand Name: VITEK® 2 AST-GN70 TEST KIT
• Common Device Name: VITEK® 2 AST-GN70 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7732828
• Report Number: 1950204-2018-00275
• Device Sequence Number: 1588097
• Product Code: LON
• UDI-Device Identifier: 03573026398477
• UDI-Public: 03573026398477
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152075
• 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): 09/16/2018

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: 11/01/2019
• Device Catalogue Number: 413401
• Device Lot Number: 5900705403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1