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

Model Number	20-006-021
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reported no calls with verigene bc-gn assays.

• Brand Name: VERIGENE BC-GN NUCLEIC ACID TEST KIT
• Common Device Name: 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
• Report Number: 3006028115-2021-00004
• Device Sequence Number: 15083693
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown