MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA HPV SCREENING ASSAY; KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS

Catalog Number	303585
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ts noted that the customer may have added the hpv test orders after the laboratory information system (lis) already had test orders for that sample, resulting in a duplicate test order.Hologic technical support (ts) reviewed available logs for hpv worklist 002503-002531-20250221-11 and noted that the sample was low target.Ts discussed the performance of the aptima hpv assay with the customer based on the information in the assay precision¿ section in the aptima hpv package insert.Hologic has not learned of any adverse patient outcomes due to this event.
Event or Problem Description
On february 25, 2025, a customer reported to hologic that they received discrepant results using aptima hpv (human papillomavirus) assay master lot 906554 on the panther instrument.Sample id # (b)(6) was tested in duplicate on hpv worklist 002503-002531-20250221-11, resulting in one negative result and one positive result.The customer retested the sample with an unknown method/test and the retest resulted positive.The customer reviewed the patient's medical history and other clinical data (cytology) and decided on reporting the hpv positive result to the caregiver/patient.No patient treatment information was provided by the customer.Hologic has not learned of any adverse patient outcomes due to this event.

• Brand Name: APTIMA HPV SCREENING ASSAY
• Common Device Name: KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS
• 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: katrina tarroja ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 21654203
• Report Number: 2024800-2025-00011
• Device Sequence Number: 20707576
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100042
• 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): 03/20/2025

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: 303585
• Device Lot Number: 906554
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/20/2025
• 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