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

Catalog Number	ASY-13822
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the panther logs and worklists and noted there were no indications of hardware or reagent preparation issues that affected results.Customer noted that they ran environmental swabs and received no indication of contamination.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, customer reported to hologic that they received discrepant chlamydia trachomatis (ct) results on three samples while using the aptima combo 2 assay (ac2, ml (b)(6)) on their panther fusion plus instrument (sn (b)(6)).On (b)(6) 2025, customer tested three sample ids (sids) (b)(6) on panther fusion plus worklist (wl) (b)(4) and received ct positive, ct positive, and ct negative results, respectively.Customer reported out these sample results.Customer suspected possible contamination due to hardware errors in the day following the initial test and decided to retest these samples on a different panther instrument (sn (b)(6)) under wl (b)(4).Upon retest, customer received ct negative, ct negative, and ct positive results for these samples sid (b)(6), respectively.Customer amended the initial results with the retest results and reported them out.Customer did not have additional patient information.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: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 23426132
• Report Number: 2024800-2025-00067
• Device Sequence Number: 9626477
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/30/2025

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 Catalogue Number: ASY-13822
• Device Lot Number: 912327
• 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: 10/07/2025
• Initial Report FDA Received Date: 10/30/2025
• 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