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

Catalog Number	ASY-15647
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
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; the most likely cause of the discrepant result was low target in the sample 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 (b)(6) 2025, a customer reported to hologic a discrepant result for sample id (sid) (b)(6) while using aptima combo 2 assay master lot 922367 on their panther instrument.On (b)(6) 2025, customer initially tested sid (b)(6) on the panther plus instrument sn (b)(6) on worklist (wl) (b)(4) and received a dual ct positive, gc positive result.Per customer lab policy, a sample is retested if there is a dual ct positive, gc positive result.On (b)(6) 2025, customer retested the dual positive sid (b)(6) on (b)(4) on a different panther instrument sn (b)(6) and received a dual ct negative, gc negative result.Customer confirmed the dual ct negative, gc negative result was reported out.Hologic has not been informed of any patient treatment or any adverse patient outcomes related 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: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 23040088
• Report Number: 2024800-2025-00061
• Device Sequence Number: 13233964
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/12/2025

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-15647
• Device Lot Number: 922367
• 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: 09/06/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown