MAUDE Adverse Event Report: Hologic, Inc. Aptima Combo 2 Assay; DNA-REAGENTS, NEISSERIA

Model Number	ASY-13823
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 a customer in spain reported to hologic that discrepant results were generated using the aptima combo 2 (ac2) assay (master lot: 930679) with panther instruments sn# (b)(6).On (b)(6) 2026, sample ids (b)(6) were tested in panther worklist id (b)(4) and each generated a chlamydia trachomatis (ct) negative result.The same samples (ids (b)(6)) were retested on another panther instrument on (b)(6) 2026, under worklist id (b)(4), and each generated a chlamydia trachomatis (ct) positive result.No information regarding patient treatment is available at this time.Hologic has not been informed of any adverse patient outcome related to this event.
Additional Manufacturer Narrative
Hologic reviewed the panther system log files provided by the customer.Review of the logs did not reveal any hardware or instrument issues that contributed to the discrepant result.Following cleaning of the sample/reagent racks and shields with bleach per protocol, no further unexpected results were observed.Aptima lysis tubes processed as a contamination check returned negative results.Hologic has not been informed of any adverse patient outcome related to this event.Hologic further reviewed the impacted master lot 930679 production records which indicated the assay lot was released per qc specifications.

• 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: maria osorio ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 50671724
• Report Number: 2024800-2026-00071
• Device Sequence Number: 21210450
• Product Code: LSL
• UDI-Device Identifier: 15420045512832
• UDI-Public: 15420045512832
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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): 09/08/2026

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: ASY-13823
• Device Lot Number: 930679
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/08/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown