MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST FLUCONAZOLE FL 256 WW S30; ETEST® FLUCONAZOLE FL 256 WW S30

Catalog Number 412350

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining false susceptible fluconazole results for candida glabrata in association with the etest® fluconazole fl 256 ww s30 (ref 412350, lot 1008297750).The customer reported observing the same issue with eight (8) patient samples.The customer performed analysis with both broth microdilution (bmd) and etest® fluconazole fl 256 ww s30.Bmd = fluconazole resistant.Etest = fluconazole susceptible.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.Note: etest® fluconazole fl 256 ww s30 (ref 412350) is not registered for use in the united states.However a similar product, etest® fluconazole fl 256 us s30 (ref 412349), is registered for use in the united states (k040560).

• Brand Name: ETEST FLUCONAZOLE FL 256 WW S30
• Type of Device: ETEST® FLUCONAZOLE FL 256 WW S30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 11793500
• MDR Text Key: 281016951
• Report Number: 9615754-2021-00154
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• PMA/PMN Number: K040560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Catalogue Number: 412350
• Device Lot Number: 1008297750
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1