MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY; MULTI-TARGET RESPIRATORY SPECIMEN NUCLEIC ACID TEST INCLUDING SARS-COV-2

Catalog Number	PRD-07400
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hologic field service engineer was dispatched to the customer site where they replaced the panther fusion thermocycler.Technical service advised the customer that all 60 positions of the thermocycler were tested for their three instruments and did not have any further false results.Hologic has evaluated the risk of false flu b positive results, in conjunction with a true sars-cov-2 positive result.Briefly, for patients that require hospitalization, the covid-19 treatment guidelines panel recommends that hospitalized patients who are suspected of having either influenza or covid-19 be started on empiric treatment for influenza with oseltamivir as soon as possible and without waiting for influenza test results.In addition, there are no clinically significant drug-drug interactions between the antiviral agents or immunomodulators that are used to prevent or treat covid-19 and the antiviral agents that are used to treat influenza.If a patient was being treated unnecessarily for flu b, then most likely the same patient would be treated for sars-cov-2.There are no clinically significant drug-drug interactions between the antiviral agents used to treat influenza and the antiviral agents or immunomodulators used to treat sars-cov-2 (1).1.Influenza and covid -19.Summary recommendations nih guidelines.Last updated sep 30,2022.Https://files.Covid19treatmentguidelines.Nih.Gov/guidelines/section/section_102.Pdf therefore, the treatment for sars-cov-2 would not be compromised.The side effects of flu b treatment are nausea, vomiting, and headache (2).2.Influenza (flu).Influenza antiviral medications: summary for clinicians.Centers for disease control and prevention.Last updated january 25, 2021.Https://www.Cdc.Gov/flu/professionals/antivirals/summary-clinicians.Htm however as noted before, hologic has an effective method of detection and correction to reduce the risk of and prevent false results from being reported due to this issue.
Event or Problem Description
On (b)(6) 2023, the customer reported to hologic that they questioned their panther fusion sars/flu a/b/rsv results completed on one panther fusion plus instrument.There was one dual positive sars and flu b result for 20 samples using assay cartridge ln 573009.The customer submitted two medwatch reports (mw5148920 and mw5148921) on 12/04/2023 and informed hologic in an email.Hologic received a copy of the submitted medwatch reports from the fda on 12/12/2023.According to the medwatch reports submitted by the customer, two of their panther fusion instruments produced false flu b positives results when testing known sars-cov-2 positive samples.The customer discovered this during assay verification on one panther fusion thermocycler, which was replaced prior to beginning patient testing.Samples were then tested on their other panther fusion instrument, and the customer claimed that specific thermocycler positions produced false flu b positive results.One false flu b positive result was released and immediately corrected, while the 19 other false flu b positive samples were not released.While there were no associated or potential adverse events reported to hologic from this event, hologic is reporting this issue in response to the customer submitted medwatch reports.
Event or Problem Description
Follow-up report.See section h10.
Additional Manufacturer Narrative
The following is a resubmission that was initially submitted as a follow up mdr (2024800-2023-00026) on 03/04/2024 by hologic.There were no additional updates as initial report contained all required information.
Event or Problem Description
Follow-up report.See section h10.
Additional Manufacturer Narrative
Section b5 stated "follow-up report.See section h10." when it should have referenced section h11.
Event or Problem Description
See section h11.

• Brand Name: PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY
• Common Device Name: MULTI-TARGET RESPIRATORY SPECIMEN NUCLEIC ACID TEST INCLUDING SARS-COV-2
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 18314887
• Report Number: 2024800-2023-00026
• Device Sequence Number: 6114955
• Product Code: QOF
• UDI-Device Identifier: 15420045515352
• UDI-Public: 15420045515352
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K222736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/19/2024

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 Catalogue Number: PRD-07400
• Device Lot Number: 573009
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 11/21/2023; Not provided; Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/04/2024; 07/17/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown