MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE BC-GN NUCLEIC ACID TEST KIT (20 TESTS)

Model Number	20-006-021
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021: customer reported no call int ctl results while utilizing the verigene bc-gn assay.There was a device malfunction, once additional information becomes available the information will be provided.
Event or Problem Description
On (b)(6) 2021: customer reported no call int ctl results while utilizing the verigene bc-gn assay.There was a device malfunction, once additional information becomes available the information will be provided.

• Brand Name: VERIGENE BC-GN NUCLEIC ACID TEST KIT (20 TESTS)
• Common Device Name: VERIGENE BC-GN
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial ave; northbrook IL 60662
• Manufacturer Contact: alina goodman ; 4088 commerical ave; northbrook, IL 60662
• MDR Report Key: 13061178
• Report Number: 3006028115-2021-00012
• Device Sequence Number: 4897774
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/22/2021

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: 04/13/2022
• Device Model Number: 20-006-021
• Device Catalogue Number: 20-005-021
• 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: 11/29/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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