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	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a customer reported to hologic a discrepant result using the aptima combo 2 assay (ac2) from master lot 919672 on the panther plus instrument (sn: (b)(6).The customer initially tested the sample on (b)(6) 2025 under worklist (b)(4) and received a dual positive result (ct positive/gc positive).The same sample was retested on (b)(6) 2025 under worklist (b)(4) and resulted dual negative (ct negative/gc negative).The customer reported out the dual negative result (ct negative/gc negative).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 that would impact the results.Hologic determined the most likely cause of the discrepant result was due to sample mishandling or a low target sample.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: 22816356
• Report Number: 2024800-2025-00053
• Device Sequence Number: 21086124
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/15/2025

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: 919672
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/15/2025
• 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