MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE PROCESSOR SP

Model Number	10-0000-07
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The service visit at katherine (b)(6) hospital.Was scheduled per capa-21-014 within work order wo-00199948.During the site visit, the elution heater required recalibration due to failing initial verification at setpoints 1 and 2.Field quality updated risk assessment question 2 to 'yes' since the setpoint temperatures failed outside the accepted limits established by the verigene i assay temperature tolerance guard band risk report ((b)(4)).Per the verigene assay temperature tolerance (guard-band) study report ((b)(4)), the study evaluated the assay performance of verigene® rp flex, ep, cdf, bc-gp and bc-gn assays at varying critical temperature parameters and established a functional range of temperature for assay tolerance above and below the nominal set points.It was determined within (b)(4), that the elution heater has a lower tolerance of -4degree celsius and an upper tolerance of greater than or equal to 5degree from the setpoint temperature 1 (75.0c) and setpoint 2 (85.0c).In reviewing the attached naplogs, setpoint 1 for the elution heater had an adjusted temperature of +86.1c and setpoint 2 had an adjusted temperature of +97.9c; both higher than the acceptable range per (b)(4).Due the finding, risk assessment question 2 was updated to 'yes'.The customer site is currently running bc-gp, bc-gn, and ep verigene assays.The elution heater verification failure can potentially impact assay performance for all three assays ran at the customer site per (b)(4).Within an 18-month timeframe from the verification failure, the customer site has not reported any patient sample false results on either assay.The customer site reported no false results for the sp processor s/n (b)(4).There is no indication of this verification failure resulting in an adverse effect to patient results.

• Brand Name: VERIGENE PROCESSOR SP
• Common Device Name: VERIGENE PROCESSOR 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: 14311544
• Report Number: 1650733-2022-00021
• Device Sequence Number: 4677059
• 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
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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
• Device Lot Number: 18128002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2018
• 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