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

Model Number 20-006-021

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

(b)(6) 2021: customer called in to report no call int ctl while using the 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)
• Type of Device: 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: 13254145
• MDR Text Key: 289455984
• Report Number: 3006028115-2021-00015
• Device Sequence Number: 1
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2021

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
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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