MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE PROCESSOR SP

Model Number 10-0000-07

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

In review of all associated customer-provided documentation and internally generated investigation notes against the criteria set forth in document 00043 (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 Description

The service visit at blanchard valley health system was scheduled per capa(b)(4) within work order (b)(4).During the site visit, the hybridization (hyb) 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 (03838).Data review per the verigene assay temperature tolerance (guard-band) study report (03768), the study evaluated 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 03838, that the hyb heater has an upper and lower tolerance of +/-2 degree celsius from the setpoint temperature 1 (38.5degc) and setpoint 2 (90degc).In reviewing the attached naplogs, setpoint 1 for the hyb heater had an adjusted temperature of +39.4c, within the range established in 03838.However, setpoint 2 had an adjusted temperature of +92.4c, 0.4c higher than the acceptable range per 03838.Due the finding, risk assessment question 2 was updated to yes.Site performance the customer site is currently running bc-gp and bc-gn verigene assays.The hyb heater verification failure can potentially impact assay performance related to the bc-gn and bc-gp assay per 03838.Within an 18-month timeframe from the verification failure, the customer site has not reported any patient sample false results on either assay.Conclusion 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
• Type of Device: 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: 14274700
• MDR Text Key: 299582183
• Report Number: 1650733-2022-00020
• Device Sequence Number: 1
• Product Code: NSU
• UDI-Device Identifier: 00840487101483
• UDI-Public: 00840487101483
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 19044007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1