MAUDE Adverse Event Report: LUMINEX CORPORATION RESPIRATORY PATHOGENS FLEX (RP FLEX) AMPLIFICATION TRAY; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Lot Number 07082124A

Device Problem False Positive Result (1227)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

We believe the problem is instrument related, as we have experienced the error across multiple lots of kits/reagents.Issue is recurring and unpredictable but limited to the respiratory pathogen panel.We are experiencing false positive results on varied analytes in the respiratory panel.No instrument errors or flags are being triggered.Most recently, a patient was reported to have influenza a, with h3 sub-type, but upon repeat testing on a separate platform, the sample was negative for influenza.When repeated on the verigene platform, both the influenza a, and h3 subtype results were negative.Prior to this recent event, we have reported 5 additional false positive cases to the vendor detailed below: np specimen tested positive for flu a, flu a/h3, hrv, piv 1, piv 4, rsv b, adeno, b.Para/bronch and b.Holmesii.Repeat: hrv positive.Np specimen tested positive for piv 2, piv 4, adeno.Repeat: negative.Bal specimen tested positive for flu b.Repeat: negative.Rp patient initially positive for influenza a, influenza a/h1, influenza a/h3, influenza b, adenovirus, hmpv, and rhinovirus.Repeated negative.Rp cap pt specimen initially positive for influenza b, rsv a and parainfluenza 1.Repeated positive for influenza b and rsv a.Currently, we are repeating all patient specimens with a positive initial result, to confirm the result prior to reporting.Since beginning this practice, we have had failure to confirm one additional sample that tested positive for bordetella initially, but negative upon repeat.Vendor is working with our team to troubleshoot the issue; however no cause has been determined to date.Manufacturer response for respiratory virus panel nucleic acid assay system25 - (b)(4) (brand not provided) (per site reporter).Manufacturer has provided the following summary: ¿this data review revealed some apparent non-specific signal on the slides, which may be due to some left-over reagent.This observation was not observed on other slides that were reviewed, suggesting the non-specific signal resulted in discrepant results between the initial and repeat test results.Discrepancies can occur due to a number of different reasons, including workflow or amplicon contamination, assay design, low level positive samples, as well as reagent or instrument issues.However, it is important to note that performance claims are established within the package insert.For example, the rp flex package insert performance claims indicate a ~97-99% negative percent agreement (npa) for the various targets, along with the associated error, when analyzing prospectively collected samples.These performance claims were established by running greater than 2000 clinical samples, compared to the 57 analyzed in during this investigation.Considering the limited sample size and assuming all reported suspected false positives are indeed false, npa ranged 96.6-98.3% for those targets and the specific sample set examined.These discrepancies are the only known recent examples at your facility.A preventative maintenance service visit was performed following these events and no other discrepancies have been reported since.¿.

• Brand Name: RESPIRATORY PATHOGENS FLEX (RP FLEX) AMPLIFICATION TRAY
• Type of Device: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial ave; northbrook IL 60062
• MDR Report Key: 13076676
• MDR Text Key: 282724068
• Report Number: 13076676
• Device Sequence Number: 1
• Product Code: OCC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2021,08/18/2021

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 Lot Number: 07082124A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 480 DA
• Patient Sex: Female
• Patient Weight: 10 KG