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

Catalog Number 414967

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) notified biomerieux of a discrepant result associated with the vitek 2 ast-ys07 test kit.The customer reported the vitek 2 ast-ys07 card found voriconazole to be susceptible for a patient strain while their reference method, sensititre, gave them resistant.The patient strain has been requested from the customer.An internal biomerieux investigation will be initiated.

• Brand Name: VITEK® 2 AST-YS07 TEST KIT
• Type of Device: VITEK® 2 AST-YS07 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: 5657736
• MDR Text Key: 45256780
• Report Number: 1950204-2016-00056
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K092454
• 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
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2016
• Device Catalogue Number: 414967
• Device Lot Number: 287346720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1