MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-YS08 TEST KIT

Catalog Number 420739

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a false susceptible flucytosine result for a candida norvengensis external quality control sample (eeq biologie prospective) in association with the vitek® 2 ast-ys08 test kit.The ast-ys08 card results were: fluconazol mic = 16 intermediate, flucytosine mic = 4 susceptible.The customer reported that the expected results were resistant for both fluconazol and flucytosine.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

The correct pma/510(k) number is k133952.

Manufacturer Narrative

This report was initially submitted in response to a customer from (b)(6) reporting a false susceptible flucytosine result for a candida norvengensis external quality control sample (eeq biologie prospective) in association with the vitek® 2 ast-ys08 test kit.An internal biomérieux investigation was performed that included testing for both fluconazole (flu) and flucytosine (fct) results with a strain of candida norvegensis on vitek® 2 ast-ys08 cards.This strain is from a biologie prospective survey (mycology 2017- sample 3a).Id testing : identification was confirmed to candida norvegensis on vitek 2 yst id card (lot 2430356103).Ast testing: · reference method to determine the intended result for fluconazole and flucytosine: broth microdilution, method used to develop the formularies "flu02n" / "fct02n" (in ast-ys08 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 -ys08 on vitek 2 v7.01 three (3) vitek 2 ast-ys08 lots were tested from sabouraud dextrose agar (sda).Vitek 2 gave the following results on the three (3) lots tested: **flu mic = 8 mg/l susceptible **fct mic = 4 mg/l susceptible the vitek 2 results are within essential agreement with the reference mic within +/- 1 doubling dilution.Conclusion: -the customer results were duplicated on the ast-ys08 cards (mic flu= 8 mg/l s and fct mic=4 mg/l s).-the vitek 2 ast-ys08 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-YS08 TEST KIT
• Type of Device: VITEK® 2 AST-YS08 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: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7182865
• MDR Text Key: 97757257
• Report Number: 1950204-2018-00020
• 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,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2018
• Device Catalogue Number: 420739
• Device Lot Number: 2880297203
• Other Device ID Number: 03573026535353
• 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: 03/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1