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

Catalog Number	ASY-13823
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the panther log files and worklists and noted there were no indications of hardware or reagent preparation issues that affected results.The discrepant result appeared to be sample related, possibly due to low target concentration or sample mishandling.Hologic has not been informed of any adverse patient outcomes related to this issue.
Event or Problem Description
On (b)(6) 2026, customer reported to hologic inconsistent sample results while performing validation testing while using the aptima combo 2 (ac2) assay on their panther fusion plus instruments.Customer confirmed that the initial test results were reported out.Customer provided logs.On (b)(6) 2026, sample id (sid) (b)(6) was initially tested on ct/gc worklist (b)(4) (ml 926168) on panther instrument (sn (b)(6) and resulted ct positive/gc negative.On (b)(6) 2026, customer retested the same sample (sid) (b)(6) on ct/gc worklist (b)(4) (ml 928004) on a different panther instrument (sn (b)(6), and the validation test resulted ct positive/gc positive.Customer did not provide any information on the patient or patient treatment.Hologic has not been informed of any adverse patient outcomes related to this issue.Instrument was operational, and no further issues were reported.

• Brand Name: APTIMA COMBO 2 ASSAY
• Common Device Name: DNA-REAGENTS, NEISSERIA
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: amy holtgraver ; 10210 genetic center drive; san diego, CA 92121 ; 8584108236
• MDR Report Key: 25384549
• Report Number: 2024800-2026-00027
• Device Sequence Number: 21000345
• Product Code: LSL
• UDI-Device Identifier: 15420045512832
• UDI-Public: 15420045512832
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/03/2026

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-13823
• Device Lot Number: 928004
• 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: Not provided
• Initial Report FDA Received Date: 06/03/2026
• 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