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

Catalog Number	ASY-13823
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a customer in france reported to hologic that a discrepant result was generated whilst using the ac2 assay (master lot: 919348) with panther instrument (serial number: (b)(6)).The incident was recorded under hologic reference number (b)(4).On (b)(6) 2025, the sample id (b)(6) was tested in panther worklist id (b)(4) and generated a chlamydia trachomatis (ct) negative /neisseria gonorrhoea (gc) negative result.The same sample (id (b)(6)) was retested on (b)(6) 2025 on the same panther instrument (worklist id (b)(4)) and generated a chlamydia trachomatis (ct) positive/neisseria gonorrhoeae (gc) negative result.On (b)(6) 2025, the same sample (id (b)(6)) was retested again, this time on another panther instrument (worklist id (b)(4)) and generated a chlamydia trachomatis (ct) positive/neisseria gonorrhoeae (gc) negative 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 ts reviewed the system logfiles provided by the customer and preliminary analysis indicates that the most likely explanation for the discrepant result is low target in the sample, either because the patient is (low) positive or because the sample was mishandled/contaminated.Review of the logs and amplification curves did not reveal any abnormalities suggestive of a hardware or instrument 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: maria osorio ; 10210 genetic center drive; san diego, CA 92121 ; 8584108109
• MDR Report Key: 23816699
• Report Number: 2024800-2025-00076
• Device Sequence Number: 13114068
• Product Code: LSL
• UDI-Device Identifier: 15420045512832
• UDI-Public: 15420045512832
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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

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: ASY-13823
• Device Lot Number: 919348
• 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: 11/28/2025
• Initial Report FDA Received Date: 12/16/2025
• 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
• Patient Sex: Unknown