MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 AST-YS05 TEST KIT

Catalog Number 411945

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Code Available (3191)

Event Date 05/12/2015

Event Type  Injury  

Event Description

A customer in the united states contacted biomérieux to report a false susceptible fluconazole result (mic = 4) for a candida glabrata organism on the vitek® 2 ast-ys05 test kit (ref 411945, lot 285346710, expiry 11jun2016).The result was reported to the treating physician.The patient isolate was sent to a reference laboratory (arup) for testing.The reference laboratory obtained a resistant result (mic = 16) for fluconazole via broth micro-dilution (bmd).The physician claims treatment failure and delay to receive appropriate treatment >24 hours.Patient therapy was modified once the result from the reference laboratory was received.Biomérieux has requested culture submittal for internal testing.

Manufacturer Narrative

Device not received by manufacturer.

Manufacturer Narrative

Two candida glabrata isolates were submitted by the customer to biomérieux for evaluation.The organism identification of the isolates was confirmed (candida glabrata) and fluconazole testing included two test kits from the same lot of ast-ys05 as that tested by the customer and two test kits from a random lot.Also tested was broth microdilution (bmd), the reference method for fluconazole.Category calls for all testing was determined using the vitek® 2 breakpoints: <=8 s, 16-32 i, >=64 r.Isolate #1: susceptible mics = 2 were obtained from the four ast- ys05 test kits; bmd gave a susceptible mic = 1.Isolate #2: susceptible mics = 2 were obtained from the customer's lot of ast-ys05 cards and from the random lot, susceptible mics = 2 and 4 were obtained.Bmd gave a susceptible mic = 2.Based on the results of the investigation testing, the vitekc 2 ast-ys05 test kits are performing as expected and within performance claims.The customer's lack of correlation between vitekv 2 and bmd methods could not be duplicated.The 2008 clsi m27-a3 and the 2012 m27-s4, reference method for broth dilution antifungal susceptibility testing of yeast, contains a note which states "when an isolate is identified as candida glabrata and the mic is <=32, it should be considered if fluconazole is appropriate in the specific clinical context.".

• Brand Name: VITEK 2 AST-YS05 TEST KIT
• Type of Device: VITEK 2 AST-YS05 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4780357
• MDR Text Key: 20755323
• Report Number: 1950204-2015-00005
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2016
• Device Catalogue Number: 411945
• Device Lot Number: 285346710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2014
• 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
• Patient Outcome(s): Required Intervention