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	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	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the system logs provided by the customer.Logfile review confirmed there were no signs of hardware issues with the instrument that could have interfered with the results.Hologic performed a risk assessment and noted no product impact.Hologic has not been informed of any patient treatment or any adverse patient outcomes related to this event.
Event or Problem Description
On (b)(6) 2024, a customer in belgium reported to hologic a potential false positive for sars-cov-2 result on a sample tested with the panther fusion sars-cov-2/flu a/b/rsv assay (cartridge ln 887495) on (b)(6) 2024.There were two samples taken from the same patient from the urgency ward.The first sample (id (b)(6)) gave a positive result for sars-cov-2 with hologic panther instrument (sn (b)(6)).The customer noted that the initial positive result was reported out to the patient.The second sample (id (b)(6)) was negative for sars-cov-2 with the respiratory panel tested on non-hologic equipment.The second sample was also analyzed on panther (on (b)(6) 2024) and was found to be negative for sars-cov-2.Afterward, the first sample was repeated on both panther and non-hologic equipment, both results were found to be sars-cov-2 negative.The customer noted that after the confirmation testing, the result was amended to negative.Hologic has not been informed of any patient treatment or any adverse patient outcomes related to this event.
Additional Manufacturer Narrative
In the initial risk assessment conducted by hologic for this complaint, the term ¿urgency ward¿ was misinterpreted as being equivalent to a ¿critical care unit¿.Upon additional review of the event details, it was clarified that ¿urgency ward¿ is equivalent to ¿emergency room¿ in belgium.Furthermore, there was no indication that the impacted individual was a transplant patient nor immuno-compromised.Based on this information, the risk of harm was re-assessed appropriately, and the probability of harm for this specific complaint was considered ¿broadly acceptable¿.As a result of this determination, hologic removes event classification of ¿serious¿ and deems this event as ¿not reportable¿.
Event or Problem Description
Follow-up report.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: geovan rich ; 10210 genetic center drive; san diego, CA 92121 ; 6199972348
• MDR Report Key: 21044637
• Report Number: 2024800-2024-00063
• Device Sequence Number: 12925267
• Product Code: QOF
• UDI-Device Identifier: 15420045515352
• UDI-Public: 15420045515352
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 12/30/2024

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 Catalogue Number: ASY-16066
• Device Lot Number: CARTRIDGE LN 887495
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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