MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER FUSION ADV/HMPV/RV ASSAY; HUMAN METAPNEUMOVIRUS (HMPV) RNA ASSAY SYSTEM

Model Number	AMR KIT, PANTHER FUSION, 96T, IVD
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other.
Event or Problem Description
Hologic became aware of a potential false positive hmpv result submitted to the fda (mdr report key (b)(4).The incident occurred on (b)(6) 2019, but hologic became aware of the incident on 01/05/2023.A patient was tested for human metapneumovirus (hmpv) and rhinovirus (rv) using the panther fusion adv/hmpv/rv assay lot: 247667.The sample was rv-positive with a strong pcr signal and hmpv-positive with a weak pcr signal.When retested, the sample test results were still rv- and hmpv-positive.The following week, two other patients test positive for both rv and hmpv with the same pcr signal result, leading the user to question the initial patient¿s sample result as a potential false positive.The information reported in the mdr is insufficient to characterize any sample as a confirmed false result.Hologic was not contacted nor made aware of any results reported, any amendments to results, or any treatment provided.User contacted the vendor, who stated they understood the cause of this issue and did not issue guidance to customers.A previous event search performed on (b)(6) 2023 found no similar complaints associated with ln: 247667 since on (b)(6) 2019; the issue with assay lot: 247667 appeared to be an isolated event.No further issues were reported.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 (1, 2).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.1.Adenoviruses: prevention and treatment.Centers for disease control and prevention.Last updated august 28, 2019.Https://www.Cdc.Gov/adenovirus/hcp/prevention-treatment.Html.2.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 hmpv.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.The mdr report submitted by the customer is consistent with the above.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 (mdr report key (b)(4).

• Brand Name: PANTHER FUSION ADV/HMPV/RV ASSAY
• Common Device Name: HUMAN METAPNEUMOVIRUS (HMPV) RNA ASSAY SYSTEM
• 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: 16296619
• Report Number: 2024800-2023-00006
• Device Sequence Number: 12635653
• Product Code: OEM
• UDI-Device Identifier: 15420045509290
• UDI-Public: 15420045509290
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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
• Device Model Number: AMR KIT, PANTHER FUSION, 96T, IVD
• Device Catalogue Number: ASY-10186
• Device Lot Number: 247667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/03/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown