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

Catalog Number 414967

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a false susceptible result when testing an external quality assessment (eqa) candida guilliermondii strain from labquality (eqa round 4 2017 - specimen s001) for antifungal susceptibility with vitek® 2 ast-ys07 (ref 414967).The customer had tested the eqa sample for identification and obtained candida guilliermondii as expected.When testing with the ast-ys07 card, they had obtained a minimal inhibitory concentration (mic) value of 2, indicating the fungus to be susceptible to fluconazole.The expected result was resistant.Labquality identified the strain as resistant with a mic value at 256 and another at 8 with e-test.The labquality (eqa round 4 2017) report defines specimen s001 as follows: "a yeast strain isolated from blood culture from a liver-transplant patient".There is no indication or report from the customer to biomérieux that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An investigation was initiated due to a false susceptible fluconazole (flu) result for a candida guillermondii eeq sample, eqa-4-2017 s001, on a ast-ys07 vitek 2 card.The expected result was flu resistant.An investigation was performed.The identification was confirmed to candida guillermondii.The broth microdilution, method used for the development of the fluconazole on the ast-ys07 card was performed in parallel of vitek 2 testing.The result was flu ref mic = 2 mg/l s.Testing of vitek 2 ast-ys07 cards from the customer lot 2870157203 and random lot 2870381213 was performed from sabouraud dextrose agar (sda).Results : susceptible flu mics (2 mg/l s) were obtained on all cards tested.In conclusion, the susceptible customer results (2 mg/l s) were reproduced in-house.The vitek 2 results are within essential agreement with the reference mic (bmd = 2mg/l s) within +/- 2 doubling dilutions.The ast-ys07 card performed as intended and no further action is required.Note: the values obtained by the lab quality reference laboratories were 8 mg/l (lab 1) and 256 mg/l (lab 2) interpreted resistant.The eucast antifungal clinical breakpoint table version 8.1 does not provide species specific mic interpretations for different antifungals for c.Guillermondii, so it is written in the lab quality report they interpreted according to the "non-species-specific breakpoints" for fluconazole : s<=2 - r>4.Using these eucast breakpoints, the value equal to 2 mg/l (reference mic and the vt2 mic) is on the breakpoint so within +/- 2 doubling dilutions the value could be considered also "resistant".Fluconazole (flu01n) is not developed to the eucast reference method.

• 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; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7215235
• MDR Text Key: 98292522
• Report Number: 1950204-2018-00040
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133817
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2018
• Device Catalogue Number: 414967
• Device Lot Number: 2870157203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1