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

Catalog Number	ASY-15648
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed all three worklists and noted no hardware or reagent preparation issues.Ts was unable to rule out sample mishandling or low target samples.Hologic performed a risk assessment and noted no product impact.Hologic has not been informed of any adverse patient outcomes related to this situation.
Event or Problem Description
On february 10th, 2025, customer reported a discrepant result using aptima combo 2 assay (ml 908987), worklist 001320-20250205-09, on panther plus instrument serial number (b)(6).Customer noted the sample was initially ran on worklist 001222-20250204-34 on panther plus instrument serial number (b)(6) using the same assay and obtained a ct negative and gc equivocal result.Customer retested the sample on worklist 001320-20250205-09 (as previously mentioned) and obtained a ct positive and gc negative result.Customer retested the sample for a second time on worklist 011015-20250205-41 on panther plus instrument serial number (b)(6) using the same assay and obtained a ct positive and gc negative result.Customer noted that they reported out the initial ct negative gc equivocal result to the patient.Customer was not provided any treatment information of the patient.Hologic has not been informed of any adverse patient outcomes related to this situation.

• 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 ; 6199972348
• MDR Report Key: 21553354
• Report Number: 2024800-2025-00009
• Device Sequence Number: 11874772
• Product Code: LSL
• UDI-Device Identifier: 15420045514966
• UDI-Public: 15420045514966
• 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): 03/07/2025

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: ASY-15648
• Device Lot Number: 908987
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/07/2025
• 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