MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-YS08 TEST KIT

Catalog Number 420739

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a false susceptible voriconazole result for a candida glabrata eeq (biologie prospective mycologie 2018-2a) sample when using the vitek® 2 ast-ys08 test kit 20 cards (ref.420739).The strain was a candida glabrata from an (b)(6) patient with esophagitis.The result obtained twice with the ast-ys08 card was susceptible (mic=1), while the expected result was resistant.There was no patient involved as the event involved an external quality control sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) reported a false susceptible voriconazole result for a candida glabrata eeq (biologie prospective mycologie 2018-2a) sample when using the vitek® 2 ast-ys08 test kit 20 cards (ref.420739).The customer did not save the strain for investigation.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.The vitek ast-ys08 lot # 2880600203 met final qc release criteria and passed qc performance testing.A quality systems (qs) review did not indicate a trend related to this complaint or card lot.

• 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; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: debra broyles ; 595 anglum road; st. louis, MO 63042 ; 3147318805
• MDR Report Key: 7678262
• MDR Text Key: 113776840
• Report Number: 1950204-2018-00250
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Catalogue Number: 420739
• Device Lot Number: 2880600203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1