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	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support reviewed all customer worklists and noted no hardware or reagent chemistry issues.Hologic technical support informed the customer that the issue was likely due to either low target samples or sample mishandling.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 june 6, 2025, a customer reported to hologic that they were questioning results of sample id (b)(6) using the aptima combo 2 assay (ac2) master lot 917920.On (b)(6) 2025, the customer received a dual positive result (ct positive / gc positive) on panther serial number (b)(6) under worklist (b)(4).The sample was retested on (b)(6) 2025 and had a dual negative result (ct negative / gc negative) on panther serial number (b)(6) under worklist (b)(4).Customer reported the same sample tube was tested both times and the dual negative result (ct negative / gc negative) was reported out.Hologic has not been informed of any patient treatment or any adverse patient outcomes related to this situation.

• 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: jiayi zheng ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 22373360
• Report Number: 2024800-2025-00040
• Device Sequence Number: 15457972
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111409
• 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): 07/01/2025

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: COMMON
• Device Catalogue Number: 302661
• Device Lot Number: 917920
• 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: 06/06/2025
• Initial Report FDA Received Date: 07/01/2025
• 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