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)(4) reported the occurrence of false susceptible flucytosine result (mic = 4¿g/ml) for candida norvegensis eeq biologie proficiency sample in association with the vitek® 2 ast-ys07 test kit.The expected result was "resistant"; no expected mic was provided for the proficiency sample.The vitek® 2 ast-ys07 flucytosine result mic = 4 is susceptible (s) using eucast breakpoints, but resistant (r) using clsi breakpoints.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the proficiency sample.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation has been initiated.

Manufacturer Narrative

A customer in (b)(6) reported the occurrence of false susceptible flucytosine result (mic = 4¿g/ml) for candida norvegensis eeq biologie proficiency sample in association with the vitek® 2 ast-ys07 test kit.An internal biomérieux investigation was performed that included testing for both fluconazole (flu) and flucytosine (fct) results on vitek® 2 ast-ys07 cards with a strain of candida norvegensis from the biologie prospective survey (mycology 2017- sample 3a).Id testing : identification was confirmed to candida norvegensis on yst card (lot 2430356103) ast testing: · reference method to determine the intended result for fluconazole and flucytosine: broth microdilution, method used to develop the formularies "flu01n" / "fct01n" (in ast-ys07 card).· flu mic = 16 mg/l intermediate · fct mic = 8 mg/l intermediate interpretation according to vitek 2 breakpoints in v7.01 : fda 2009 breakpoints for candida / fluconazole s /=64.Fda 2012 breakpoints for candida / flucytosine : s /=32.Note: for antifungals, essential agreement between vitek® 2 card and reference method mics is +/- 2 doubling dilutions.· products & system incriminated: -*ast -ys07 on vitek 2 v7.01 three (3) vitek 2 ast-ys07 card lots were tested from sabouraud dextrose agar (sda).Vitek 2 gave the following results: **flu mic = 16 mg/l i on the three (3) lots tested **fct mic = 4 mg/l s on two (2) lots , 8 mg/l i on the third lot.The vitek 2 results are within essential agreement with the reference mic within +/- 1 doubling dilution.Note: according to fsca 2509 (released april 2015), fct results from ast-ys07 cards (fct01n formulation) should not be reported for any organism.Conclusion: -we duplicated the customer results on ast-ys07 cards (mic flu=16 mg/l i and fct mic=4 mg/l s).-]the vitek 2 ast-ys07 cards perform as intended.The vitek 2 values are within essential agreement with the reference results obtained in bmd.-the reference mic for both fluconazole and flucytosine are in the middle of the breakpoints, so the strain can be susceptible or resistant within +/- 2 doubling dilutions.-->borderline strain.

• 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: 7104475
• MDR Text Key: 95746868
• Report Number: 1950204-2017-00443
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133952
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2018
• Device Catalogue Number: 414967
• Device Lot Number: 2870235203
• 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: 01/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1