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

Catalog Number	302551
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic thoroughly reviewed the panther instrument logs and customer worklists and noted no indication of an underlying hardware issue.Hologic determined the most likely cause of the discrepant result was a low target sample.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
On (b)(6) 2025, a customer reported to hologic a discrepant result on panther instrument (serial number: (b)(6) using the aptima hpv (human papillomavirus) assay (master lot: 909954).The customer reported that per lab iqa procedures, they select random samples to retest.On (b)(6) 2025, sample (b)(6) initially resulted hpv negative under worklist(b)(4).On the same day, the same sample was retested as sample id (b)(6) under worklist (b)(4) and resulted hpv positive.On (b)(6) 2025, the customer decided to retest the sample (b)(6) from the original thinprep vial and sample resulted positive under worklist (b)(4).The customer reported the first valid result (negative result from (b)(6) 2025).Hologic has not been informed of any patient treatment or any adverse patient outcomes related 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: jiayi zheng ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 22840306
• Report Number: 2024800-2025-00055
• Device Sequence Number: 9635019
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/19/2025

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: 302551
• Device Lot Number: 909954
• 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: 07/30/2025
• Initial Report FDA Received Date: 08/19/2025
• 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