MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-YS07 TEST KIT

Catalog Number 414967

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in italy notified biomerieux of a discrepant result associated with vitek 2 ast-ys07 test kit.The customer reported the vitek 2 ast-ys07 card found fluconazole to be susceptible for a patient strain while their reference method, sensititre, gave them resistant.The patient strain has been requested from the customer.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer reported false susceptible results for voriconazole (vrc) and fluconazole (flu) on vitek 2 cards (ast-ys07), for a strain of candida albicans, while the customer reference method (sensititre), gave a resistant result.Customer results: strain was subcultured on cba and sda media.Ast-ys07 - lot#- 287346720tested on vitek 2 v7.01: voriconazole (vrc) minimum inhibitory concentration (mic): <=0.125mg/l |s fluconazole (flu) minimum inhibitory concentration (mic): <=1mg/l |i interpretations according to eucast breakpoints (document version 8.0): voriconazole [s<=0.125- r > 0.125] and for fluconazole [s <=2 - r >4].An internal biomérieux investigation was performed.Results are as follows: lot numbers utilized: vitek 2 (v7.01), ast-ys07 | sda subculture, lot-287346720 (customer lot), lot-287378322 (random lot).Reference method: brother microdilution (bmd) which is the reference method used for voriconazole (formulation vrc01n) and for fluconazole (formulation flu01n) developments.Bmd results (visual reading): voriconazole (vrc) minimum inhibitory concentration (mic): <= 0.03mg/l | s, fluconazole (flu) minimum inhibitory concentration (mic): =0.25mg/l | s.It was noted that the mic reading for both drugs was determined to be >= 50% growth inhibition compared to the drug free control.Investigation conclusion: for voriconazole, light growth was observed in all wells of the microplate which could explain the resistant result obtained by the sensititre automate in conclusion, the minimum inhibitory concentration obtained for both voriconazole (vrc) and fluconazole (flu) on the customer and random lots were as follows: voriconazole (vrc) mic: <= 0.125mg/l | s, fluconazole (flu) mic: <=1 mg/l | s.These results are in essential agreement with the reference methods without error of category.The vitek 2 cards are performing as expected.No further action is required.

• Brand Name: VITEK® 2 AST-YS07 TEST KIT
• Type of Device: VITEK® 2 AST-YS07 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: jonathan nonnemacher ; 100 rodolphe street; durham, NC 27712 ; 9196203396
• MDR Report Key: 5646329
• MDR Text Key: 45031586
• Report Number: 1950204-2016-00053
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2016
• Device Catalogue Number: 414967
• Device Lot Number: 287346720
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1