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

Catalog Number	302661
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a customer reported to hologic high levels of positive results while using the aptima combo 2 assay (lot number: 909770) on the panther instrument (serial number: (b)(6)).On (b)(6) 2025, sample id (b)(6) initially tested ct negative/gc positive in worklist (b)(4).On (b)(6) 2025, the same sample was retested on worklist (b)(4) and resulted ct negative/gc negative.Customer confirmed the ct negative/gc negative retest result was reported out.Hologic has not been informed of any patient treatment or any adverse patient outcomes related to this situation.
Additional Manufacturer Narrative
Hologic technical support thoroughly reviewed customer logs and did not identify any evidence of hardware or reagent preparation issues.Hologic performed a risk assessment and noted no product impact.Hologic determined the most likely cause of the discrepant result is low gc target in sample id (b)(6).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: jiayi zheng ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 21987536
• Report Number: 2024800-2025-00016
• Device Sequence Number: 8312619
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/08/2025

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: 909770
• 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: 04/09/2025
• Initial Report FDA Received Date: 05/08/2025
• 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