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  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported the occurrence of false susceptible fluconazole result for biologie prospective candida norvegensis strain in association with the vitek® 2 ast-ys08 test kit.No retest was performed for this survey strain.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 biologie prospective survey strain.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted in response to a customer in (b)(6) reporting the occurrence of false susceptible fluconazole result for biologie prospective candida norvegensis strain in association with the vitek® 2 ast-ys08 test kit.No retest was performed for this survey strain.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; 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: 7033431
• MDR Text Key: 93208192
• Report Number: 1950204-2017-00382
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2018
• Device Catalogue Number: 420739
• Device Lot Number: 2880150203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1