MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE I SP

Model Number	10-0000-07
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The service visit at kaiser permanente regional reference lab - (b)(4) was scheduled for a 12 month pm within work order: (b)(4).During the site visit, the hybridization (hyb) heater required recalibration due to failing initial verification at setpoint 2.Field quality updated risk assessment questions 7 and 8 were updated to 'yes' since the setpoint temperature failed outside the accepted limits established by the verigene i assay temperature tolerance guard band risk report (b)(4).
Additional Manufacturer Narrative
In review of all associated customer-provided documentation and internally generated investigation notes against the criteria set forth in document (b)(4) (medical device reporting standards operating procedure), this complaint does meet the requirements for an mdr in the countries where this product is sold or distributed.Filing individual mdr out of abundance of caution due to the remote possibility of a false result contributing to a death or serious injury.

• Brand Name: VERIGENE I SP
• Common Device Name: VERIGENE I SP
• Manufacturer (Section D): LUMINEX CORPORATION; 12212 technology blvd; austin TX 78727
• Manufacturer Contact: jennifer svoboda ; 12212 technology blvd; austin, TX 78727
• MDR Report Key: 15170053
• Report Number: 1650733-2022-00046
• Device Sequence Number: 5121070
• Product Code: NSU
• UDI-Device Identifier: 00840487101483
• UDI-Public: 00840487101483
• 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): 08/04/2022

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 Model Number: 10-0000-07
• Device Catalogue Number: 10-0000-07
• 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: 07/15/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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