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

Model Number	ASY-16066
Medical Device Problem Codes	Imprecise or Erratic Results (4059); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On december 16, 2024, customer relayed to hologic that they had sample id (b)(6) result as sars-cov-2 and rsv positive with our fusion sars-cov-2/flu a/b/rsv assay (cartridge lot 887495) on their panther fusion (sn (b)(6)) under worklist id (b)(6) where the same sample repeated as only rsv positive when retested on the panther fusion under the same worklist id.Sample also retested as only rsv positive when repeated on the genexpert platform.The sample was stored at ambient temperature before the test, and stored at +2 to +8°c after the test.Analysis of the sample curve data found no sample handling issues with normal amplification.Customer performed retesting due to it being a dual positive.The dual positive result was automatically reported out before being amended to being only rsv positive.The sample was from the emergency/urgent care ward.Information about any treatment performed is unknown and case troubleshooting is ongoing at this time.
Event or Problem Description
On december 16, 2024, customer relayed to hologic that they had sample id (b)(6) result as sars-cov-2 and rsv positive with our fusion sars-cov-2/flu a/b/rsv assay (cartridge lot 887495) on their panther fusion (sn (b)(6)) under worklist id (b)(6) where the same sample repeated as only rsv positive when retested on the panther fusion under the same worklist id.The dual positive result was automatically reported out before being amended to being only rsv positive.The sample was from the emergency/urgent care ward.Information about any treatment performed is unknown and case troubleshooting is ongoing at this time.
Event or Problem Description
Follow-up report.See section h11.
Additional Manufacturer Narrative
Additional follow-up and troubleshooting with customer found they were experiencing a contamination event that has since been resolved.Any patient treatment still remains unknown.
Event or Problem Description
Follow-up report correcting imdrf codes now that additional information is available.

• Brand Name: HOLOGIC RESPDIRECT COLLECTION KIT; 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: zachary hansen ; 10210 genetic center drive; san diego, CA 92121 ; 9519739240
• MDR Report Key: 21137774
• Report Number: 2024800-2025-00003
• Device Sequence Number: 20752466
• Product Code: QOF
• UDI-Device Identifier: 15420045515352
• UDI-Public: 15420045515352
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 01/13/2025

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: ASY-16066
• Device Lot Number: 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: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 07/14/2025; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown