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/ASY-16066
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the customer reported to hologic that they suspected one sample was a false positive for sars-cov-2, flu a, and rsv.The customer was using the sars-cov-2/flu a/b/rsv assay, reagent cartridge lot 884490, on the panther fusion instrument (sn (b)(6) ).The sample in question was initially tested on (b)(6) 2023 and resulted positive for sars-cov-2, flu a, and rsv.Customer questioned the sample result since all positive analytes had similar ct values.The same sample tube was retested on a non-hologic platform the same day and resulted negative for sars-cov-2, flu a, and rsv.Once the result on the non-hologic platform was obtained, the customer checked the curves for this sample and suspected that it was a false triple positive.Customer then retested the same sample tube and a new fusion tube, both times resulting negative for all four analytes.The triple positive result was reported to the patient, which goes against the sars-cov-2/flu a/b/rsv assay package insert to retest the sample and confirm results since triple infections are rare.The customer could not confirm whether the patient received treatment or if the result was amended.There were no associated/reported adverse events.
Additional Manufacturer Narrative
Hologic subject matter expert (sme) reviewed the customer¿s logs and noted that the amplification curve signal displayed an initial rise in signal intensity but remained relatively flat throughout the assay run.The amplification curves did not match a typical ¿true¿ amplification akin to a true positive sample.Hologic technical support (ts) reviewed the logs and did not observe any hardware errors for the sample in question but did see sporadic assay processing error flags throughout the worklists.Ts indicated that the repeat test was a valid run, but since the customer reported the triple positive results before performing retest, this was deemed to be outside the package insert instructions.Hologic product applications specialist (pas) reviewed the logs and fluorescence curves for the sample in question.Most fluorescence curves for the sample in question had the same pattern with a jump in the curve.Other samples tested in the same thermocycler well had normal curves.Pas did not observe any significant hardware errors.After discussing with r&d, pas suspected the abnormal sample result may have been due to the reaction vial, possibly an unexpected movement or artefact in the tube.Customer reported no further issues.Hologic completed a risk assessment.No patient harm was reported to hologic in association with this issue.Risk from standard treatment of sars-cov-2, flu a, or flu b is considered low.Per the assay package insert, results for this test must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.Since triple infections are rare, the package insert recommends retesting to confirm results.

• 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: 18057967
• Report Number: 2024800-2023-00017
• Device Sequence Number: 6962432
• Product Code: QOF
• UDI-Device Identifier: 15420045515352
• UDI-Public: 15420045515352
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 11/02/2023

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/ASY-16066
• Device Lot Number: 884490
• 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: 10/17/2023
• Initial Report FDA Received Date: 11/02/2023
• 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
• Patient Sex: Unknown