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

Catalog Number 20-005-021

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

(b)(6) 2021 customer called in to report 2 (two) no call int ctl while using the bc-gn assay.The customer reported additional 16 no -call between (b)(6) 2021 and (b)(6) 2021.There was a device malfunction, there was no adverse event reported at the time of the events.

• Brand Name: VERIGENE BC-GN NUCLEIC ACID TEST KIT (20 TESTS)
• Type of Device: VERIGENE BC-GN
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial ave; northbrook IL 60662
• Manufacturer Contact: alina goodman ; 4088 commercial ave; northbrook, IL 60662 ; 8474009077
• MDR Report Key: 14349798
• MDR Text Key: 299862930
• Report Number: 3006028115-2022-00001
• Device Sequence Number: 1
• Product Code: PEN
• 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: Non-Healthcare Professional
• Type of Report: Initial

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 Catalogue Number: 20-005-021
• Device Lot Number: 101321021B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2021
• 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