MAUDE Adverse Event Report: BIOMÉRIEUX INC. AST-YS08 TEST KIT 20 CARDS - 420739

Catalog Number 420739

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: the vitek® 2 fungal susceptibility card is intended for use with the vitek® 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.Issue description: a customer in the netherlands notified biomérieux of a false susceptible fluconazole for candida albicans associated with the vitek 2 ast-ys08 test kit - ref.420739, lot 2882427503.This complaint documents a second lot number associated with (b)(4).Ast-ys08, id= candida albicans, fluconazole = s.External lab: fluconazole >64/r.At the time of the global assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.

Manufacturer Narrative

This investigation was initiated due to discrepant results with candida albicans and voriconazole, amphotericin b and fluconazole drugs on vitek 2 v9.02 ast-ys08 card.The submitted customer strain was subcultured on sda (sda bmx) media under aerobic atmosphere and the identification to candida albicans was confirmed on vitek 2 yst card.The eucast breakpoints are not validated with ast-ys08 card.Then, the reference method and vitek 2 were analyzed using fda (vrc), clsi (flu) and literature (amb) breakpoints.The broth microdilution (bmd) which was the reference method used for voriconazole development on ast-ys08 card was tested and gave : ref mic vrc > 4 mg/l r.The broth microdilution (bmd) which was the reference method used for fluconazole development on ast-ys08 card was tested and gave : ref mic flu > 64 mg/l r.The broth macrodilution which was the reference method used for amphotericin b development on ast-ys08 card was tested.Ref mic amb = 1 mg/l s.On vitek 2 (aes parameters: copy of global european based+phenotypic ), the testing including ast-ys08 card from the customer lot (cl1: 2882456403), from the customer lot 2 (cl2: 2882427503) and from a random lot (rl: 2882509503) was performed.The results on vitek 2 gave: vrc vitek 2 mics = 4 mg/l r on cl1 and cl2; = 1 mg/l s on rl.Flu vitek 2 mics = 4 mg/l sdd on three lots tested.Ab vitek 2 mics = 8 mg/l r on cl1 and cl2; = 16 mg/l r on rl.Conclusion: the voriconazole customer¿s results are partially reproduced in-house.The vitek 2 vrc mic (vrc vitek 2 mic = 1 mg/l s) is an essential agreement error compared to the reference mic (vrc ref mic > 4 mg/l r) leading to a very major error of category.The vitek 2 vrc mics (vrc vitek 2 mic = 4 mg/l r) are in agreement compared to the reference mic (vrc ref mic > 4 mg/l r) without any error of category.-note: a limitation is included in the package insert of the ast-ys08 as detailed: ¿the ability of the ast card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing : [¿] voriconazole (vrc01n): candida albicans - the fluconazole susceptible customer¿s results are not reproduced in-house.The vitek 2 flu mics (flu vitek 2 mic = 4 mg/l sdd) are essential agreement errors compared to the reference mic (flu ref mic > 64 mg/l r) and they lead to minor errors of category.- the amphotericin b customer¿s results are reproduced in-house.The vitek 2 ab mics (vrc vitek 2 mic = 8 or = 16 mg/l r) are essential agreement errors compared to the reference mic (amb ref mic = 1 mg/l s) leading to major errors of category.The isolate will be added to the r&d stock collection pending customer approval.Ast-ys08, 2882456403 (cl1), 2882427503 (cl2) and 2882509503 (rl) met final qc release criteria.The lots passed qc performance testing.

Event Description

Intended use: the vitek® 2 fungal susceptibility card is intended for use with the vitek® 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.Issue description: a customer in the netherlands notified biomérieux of a false susceptible fluconazole for candida albicans associated with the vitek 2 ast-ys08 test kit - ref.420739, lot 2882427503.This complaint documents a second lot number associated with cn-532736.Ast-ys08 id= candida albicans fluconazole = s external lab: fluconazole >64/r at the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.

• Brand Name: AST-YS08 TEST KIT 20 CARDS - 420739
• Type of Device: AST-YS08 TEST KIT 20 CARDS
• Manufacturer (Section D): BIOMÉRIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer (Section G): BIOMÉRIEUX INC; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 17442383
• MDR Text Key: 320223626
• Report Number: 1950204-2023-00011
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420739
• Device Lot Number: 2882427503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1