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	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a customer reported to hologic that they received discrepant results using the aptima combo 2 assay (ac2) master lot 913491 on the panther plus instrument (serial number: (b)(6).On (b)(6) 2025, sample id (b)(6) was initially run on worklist (b)(4) and resulted ct positive and gc positive.The same sample id was retested the next day under worklist (b)(4) and resulted ct negative and gc negative.Customer noted they were holding results until a log review was performed.Per customer lab policy, the sample is retested if there is a dual positive result.Customer did not confirm if the dual positive or the negative result was reported out.Hologic has not been informed of any patient treatment or any adverse patient outcomes related to this event.
Additional Manufacturer Narrative
Hologic reviewed all customer worklists and noted no hardware or reagent preparation issues.To exclude contamination, hologic advised the customer to perform a general lab cleaning and a run known ct positive and blank panels before running the instrument again.Hologic reviewed post-cleaning logs and noted controls and blanks resulted as expected.Hologic determined the most likely cause of the discrepant result was due to 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.

• 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: 22535784
• Report Number: 2024800-2025-00044
• Device Sequence Number: 18014302
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/17/2025

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: 913491
• 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: 06/23/2025
• Initial Report FDA Received Date: 07/17/2025
• 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