MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA COMBO 2 ASSAY; DNA-REAGENTS, NEISSERIA

Model Number	COMMON
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed the logs and worklists and found no evidence of relevant hardware errors or that there were reagent preparation or contamination issues.Ts advised customer that per the ac2 package insert, the first valid result should be reported.Hologic performed a risk assessment and noted no product impact.Hologic has not been informed of any adverse patient outcomes related to this issue.
Event or Problem Description
On (b)(6) 2025, a customer reported a discrepant result using the aptima combo 2 (ac2) assay on their panther instrument.On (b)(6) 2025, sample id (b)(6) resulted as ct positive, gc negative with master lot 915869 on worklist (b)(4).Customer reported they have made it their lab policy to retest any positive result with an rlu value below 1000.On (b)(6) 2025, customer reran the sample using master lot 922619 on worklist (b)(4) where it resulted as double ct negative / gc negative.Customer relayed the initial positive result was held back, but due to how their lis was programmed, the negative result was transmitted to the caregiver.Hologic has not learned of any adverse patient outcomes due to this event.

• Brand Name: APTIMA COMBO 2 ASSAY
• Common Device Name: DNA-REAGENTS, NEISSERIA
• 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 ; 10210 genetic center drive; san diego, CA 92121 ; 9519739240
• MDR Report Key: 23324701
• Report Number: 2024800-2025-00065
• Device Sequence Number: 10573295
• Product Code: LSL
• UDI-Device Identifier: 15420045512894
• UDI-Public: 15420045512894
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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

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: COMMON
• Device Catalogue Number: ASY-13955
• Device Lot Number: 915869, 922619
• 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: 09/24/2025
• Initial Report FDA Received Date: 10/17/2025
• 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