MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 ANC TEST KIT

Catalog Number 21347

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

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

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted as part of an fda request regarding supplemental reports that did not have an initial report on file.The initial report was originally submitted as 1950204-2016-00130 in error.A supplemental report for 1950204-2016-00130 has also been submitted to document the error and correction.

Event Description

A customer in (b)(6) contacted biomérieux to report a discrepant organism identification in association with the vitek® 2 anaerobic and corynebacteria (anc) identification (id) test kit.Propionibacterium species was misidentified as atopodium vaginae.Upon obtaining atopodium vaginae result for a male patient, an alternate method of testing (crystal) was employed.The result of propionibacterium agnes (or granuslosum) was obtained.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.Culture submittals have been requested by biomérieux for internal investigation.An internal biomérieux investigation will be initiated.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 5407895
• MDR Text Key: 280455679
• Report Number: 1950204-2016-00004
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244379420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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