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

Catalog Number	PRD-05571
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a customer reported to hologic that they received discrepant results for two sample ids (sids) (b)(6) while using the aptima combo 2 assay master lot 917189.On (b)(6) 2025, customer originally ran sid (b)(6) on the panther plus instrument sn (b)(6) on worklist (wl) (b)(4), which resulted in ct positive and gc positive.The same sample was later rerun on the panther plus instrument sn (b)(6) on (b)(6) 2025, on wl (b)(4) and resulted ct negative and gc negative.Likewise, on (b)(6) 2025, customer originally ran sid (b)(6) on wl (b)(4), which produced a dual ct/gc positive result.The same sample was rerun on the panther plus instrument sn (b)(6) on (b)(6) 2025, on wl (b)(4) and produced a dual ct/gc negative result.Per customer lab policy, the sample is retested if there is a dual ct/gc positive result.Customer confirmed the dual ct/gc negative result was reported out.Hologic has not been informed of any patient treatment or any adverse patient outcomes related to this event.
Additional Manufacturer Narrative
Hologic technical support reviewed all customer worklists and noted no indications of hardware, reagent preparation, or contamination issues.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
Follow-up report.See section h11.
Additional Manufacturer Narrative
The event description in the initial report contained an error in the listing of the two affected sample ids (sids) within the first sentence only.The corrected event description is as follows: on july 7, 2025, a customer reported to hologic that they received discrepant results for two sample ids (sids) (b)(6) while using the aptima combo 2 assay master lot 917189.On (b)(6) 2025, customer originally ran sid (b)(6) on the panther plus instrument sn (b)(6) on worklist (wl) 003382-20250602-05, which resulted in ct positive and gc positive.The same sample was later rerun on the panther plus instrument sn (b)(6) on (b)(6) 2025, on wl 010208-20250604-12 and resulted ct negative and gc negative.Likewise, on (b)(6) 2025, customer originally ran sid (b)(6) on wl 003382-20250603-03, which produced a dual ct/gc positive result.The same sample was rerun on the panther plus instrument sn (b)(6) on (b)(6) 2025, on wl 002484-20250605-20 and produced a dual ct/gc negative result.Per customer lab policy, the sample is retested if there is a dual ct/gc positive result.Customer confirmed the dual ct/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: 22579957
• Report Number: 2024800-2025-00046
• Device Sequence Number: 20829586
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 08/12/2025

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: PRD-05571
• Device Lot Number: 917189
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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