MAUDE Adverse Event Report: HOLOGIC INCORPORATED PANTHER FUSION ADV/HMPV/RV ASSAY; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Model Number	9120900000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Viral Infection (2248)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial report: on (b)(6) 2021, a field application specialist (fas) reported on behalf of a customer that the customer suspected high concentration rhinovirus (rv) samples are affecting the other fusion respiratory analytes in the panther fusion adv/hmpv/rv (amr) assay.The customer has two panther-fusion instruments and requested hologic to review the logs.The customer provided panther fusion amr data from 06/05/2021-07/27/2021 ((b)(4)) and 07/08/2021-08/03/2021 ((b)(4)).Hologic confirmed on 8/25/2021 that there were false results from the data provided.Customer reported the issue to the fda (mw5103733) through the fda's medwatch program.Hologic was then notified by the fda on 9/20/2021.Treatment of adenovirus, hmpv, and rv is supportive; there are no fda-approved antivirals to improve the disease course.These infections are usually mild, often with symptoms of the common cold, and do not require medical care.A false positive would not be anticipated to have significant impact on patient care, other than the possibility of delay in diagnosis for a treatable cause of the patient's symptoms, if present.Adenoviruses: prevention and treatment.Centers for disease control and prevention.Last updated august 28, 2019.Https://www.Cdc.Gov/adenovirus/hcp/prevention-treatment.Html human metapneumovirus (hmpv) clinical features.Centers for disease control and prevention.Last updated september 5, 2019.Https://www.Cdc.Gov/surveillance/nrevss/hmpv/clinical.Html the overall risk is considered broadly acceptable and the probability of occurrence of harm is considered remote.In this complaint, the hmpv positive results are primarily occurring when the sample has a rv positive result.If a patient presented symptoms associated with a respiratory infection, the patient may be given medicines to manage their symptoms, regardless of the patient's hmpv, adv and/or rv results.Thus, a patient would not be impacted if they obtained a positive result for rv, in addition to a potential false positive result for.The panther fusion amr package insert warns customers of potential false positive hmpv or adv results in samples containing high rv content in the limitations section.There is no potential for adverse event due to the issue.Hologic is only reporting the issue through the mdr process because the customer reported it to fda (mw5103733).
Additional Manufacturer Narrative
Original report was coded against procode lsl.The mdr reported was due to false results due to high concentration of rhinovirus (rv) samples that are affecting the other fusion respiratory analytes in the panther fusion adv/hmpv/rv (amr) assay.Because this mdr relates to a respiratory viral panel multiplex nucleic acid assay, the procode should be updated to occ.Updated information in section d to align changes made from procode lsl to occ: - d1 brand name: from panther fusion instrument to panther fusion adv/hmpv/rv assay - d2 common device name: from in-vitro diagnostic to respiratory virus panel nucleic acid assay system, updated catalog # from 902615 to prd-04330 - d4 updated the eua authorized procode: from lsl to qjr, updated unique identifier (udi) #: from (b)(4) to (b)(4).Updated g5 pma/510(k): from k111409 to k172629.
Event or Problem Description
Supplemental report (see section h11 for additional corrections): fda requested for hologic to provide a supplementary report with the corrected procode information for mdr # 2024800-2021-00010.Original report was coded against procode lsl.The mdr reported was due to false results due to high concentration of rhinovirus (rv) samples that are affecting the other fusion respiratory analytes in the panther fusion adv/hmpv/rv (amr) assay.Because this mdr relates to a respiratory viral panel multiplex nucleic acid assay, the procode should be updated to occ.

• Brand Name: PANTHER FUSION ADV/HMPV/RV ASSAY
• Common Device Name: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• MDR Report Key: 12617312
• Report Number: 2024800-2021-00010
• Device Sequence Number: 11829895
• Product Code: OCC
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K172629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 9120900000
• Device Catalogue Number: PRD-04330
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other