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

Model Number	20-011-021
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) 2021 customer reporting no call int ctl on qc and patient samples while utilizing the verigene bc-gn assay.Ts requested data and sent a return label to the customer and will send another blue usb to the customer as well.Per so 280785 the customer ordered 4 kits of verigene bc-gn assay with et lot 101321021b.Ts switched risk analysis question 2, "did the device malfunction, fail to meet any labeled claim, or otherwise fail to perform as described in its intended use?" to a yes.12.21.21 ts requested approval to send the customer 4 kits of the verigene bc-gn assay.12.22.21 ts received approval to send the customer 4 verigene bc-gn kits to the customer due to the no call int ctl (see email).Ts placed the order to send these kits to the customer.12.29.21 per fedex tracking (b)(4), shipment arrived at customer site and packages were signed for by (b)(6).Customer confirmed receipt and noted 2 boxes were missing from shipment.01.03.22 customer reported that the remaining boxes arrived 12.30.31 with no issues.

• 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 commercial ave; northbrook, IL 60662
• MDR Report Key: 14349797
• Report Number: 3006028115-2022-00002
• Device Sequence Number: 4613414
• Product Code: PEN
• UDI-Device Identifier: 00840487101698
• UDI-Public: 00840487101698
• 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): 05/10/2022

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: 20-011-021
• 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: 12/20/2021
• Initial Report FDA Received Date: 05/10/2022
• 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