MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE I BC-GN ASSAY; VERIGENE ! BC-GN ASSAY

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 11/04/2020

Event Type  malfunction  

Event Description

A customer had reported a false negative ctx-m marker while utilizing verigene bc-gn assay, a change in therapy resulted based on the verigene results.No patient harm based on the change in therapy was reported.The verigene bc-gn consumable was not available.Verigene reader and processor used with the consumable, were evaluated on 05 nov 2020 for a malfunction, there was no indication of a device malfunction.This investigation is ongoing, if additional information becomes available a follow-up report will be submitted.

• Brand Name: VERIGENE I BC-GN ASSAY
• Type of Device: VERIGENE ! BC-GN ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial avenue; northbrook IL 60062
• Manufacturer Contact: alina goodman ; 4088 commercial avenue; northbrook, IL 60062 ; 8474009077
• MDR Report Key: 11046564
• MDR Text Key: 223399172
• Report Number: 3006028115-2020-00003
• Device Sequence Number: 1
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 20-005-021
• Device Lot Number: 082620021A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2020
• 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
• Patient Outcome(s): Other