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

Catalog Number	302661
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed the customer worklists and noted no hardware or reagent preparation issues.Hologic determined the most likely cause of the discrepant result is potential sample mishandling or 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.
Event or Problem Description
On (b)(6) 2025, customer reported a discrepant result using aptima combo 2 (ac2) assay master lot 921141 on panther plus instrument.On (b)(6) 2025, sample sid (b)(6) was tested using ac2 (b)(4) on panther plus instrument serial number (b)(6) and returned a ct positive / gc positive result.Hologic technical support informed the customer that per aptima combo 2 assay package insert, the first valid result for each analyte is the result that should be reported.Customer noted they were aware, but per their laboratory protocol, they are required to retest dual positive samples with rlu < 1900.On (b)(6) 2025, the same sample sid (b)(6) was retested using ac2 (b)(4) on panther plus instrument serial number (b)(6) and returned a ct negative / gc negative result.Customer reported out the ct negative / gc negative result to the physician/patient.Customer was not aware of any patient treatment.Hologic has not learned of any adverse patient outcomes due 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: geovan rich ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 22845763
• Report Number: 2024800-2025-00056
• Device Sequence Number: 18537009
• 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): 08/19/2025

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: 302661
• Device Lot Number: 921141
• 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: 08/17/2025
• Initial Report FDA Received Date: 08/19/2025
• 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