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

Catalog Number 414967

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported the occurrence of a false susceptible fluconazole result for candida albicans in association with the vitek® 2 ast-ys07 test kit.Etest fluconazole provided a resistant result.Repeat testing obtained the same respective results.The customer reports a delay in reporting due to the additional testing performed.The patient was treated with a different antimycoticum.The customer sent the patient strain to a reference laboratory.The reference laboratory obtained results of resistant to fluconazole (test method unknown), confirming the vitek® 2 ast-ys07 result to be discrepant.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.Internal biomérieux investigation will be conducted.

Manufacturer Narrative

A biomerieux investigation was initiated due to a false susceptible fluconazole result on the ast-ys07 card for a candida albicans isolate, compared to etest® and reference lab results (resistant).The customer also observed the same issue on voriconazole.The reference method was performed to determine the intended results for fluconazole and voriconazole bmd (broth microdilution), compared with vitek® 2 (v6.01) and ast-ys07 cards.Category interpretations based on vitek® 2 breakpoints were: fluconazole: s/=64.Voriconazole: s/=4.Two different lots of ast- ys07 cards were tested: the customer lot 287394320 and a random lot 287389420.Test results obtained with bmd: - fluconazole reference mic >64mg/l resistant.-voriconazole reference mic>16 mg/l resistant.Results confirmed those obtained by the reference institute.On vitek® 2, the results obtained on both lots tested were flu mic <= 1mg/l s and vrc mic <=0.125mg/l s.The investigation duplicated the customer results.The investigation concluded the submitted isolate has an atypical biochemical profile.

• 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; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5949551
• MDR Text Key: 54694576
• Report Number: 1950204-2016-00122
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 414967
• Device Lot Number: 287394320
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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