MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE BC-GN NUCLEIC ACID TEST KIT

Model Number 20-006-021

Device Problem Defective Component (2292)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

Submitted on 11/23/2021 by a former luminex employee.There is no copy of the acknowledgement available within luminex's records and one cannot be recovered due to luminex's email retention policy lasting 13 months.The mdr is therefore being resubmitted to ensure receipt.A copy of the acknowledgement will be maintained with the mdr record.

Event Description

Customer reported no calls with verigene bc-gn assays.

• Brand Name: VERIGENE BC-GN NUCLEIC ACID TEST KIT
• Type of Device: VERIGENE BC-GN
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial ave; northbrook IL 60062
• Manufacturer Contact: alina goodman ; 4088 commercial ave; northbrook, IL 60062
• MDR Report Key: 16188804
• MDR Text Key: 308841922
• Report Number: 3006028115-2021-00004
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

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 Expiration Date: 04/22/2022
• Device Model Number: 20-006-021
• Device Catalogue Number: 20-009-021
• Device Lot Number: 101321021B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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