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

Catalog Number	303012
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
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 issue.
Event or Problem Description
On (b)(6), 2025, customer reported a discrepant result using aptima hpv assay on panther instrument.The sample was initially ran on hpv worklist (b)(4) using the aptima hpv assay (ml: (b)(6)) and resulted hpv negative.Customer noted the initial hpv negative result was reported out and questioned by the physician.Customer retested different aliquots as well as the original sample on hpv worklist (b)(4) on panther instrument sn# (b)(6) using the aptima hpv assay (ml: 908238) and obtained hpv positive results each time.Customer subsequently amended the result to hpv positive.Customer did not provide any patient treatment information.Hologic has not been informed of any adverse patient outcomes related to this situation.

• 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: geovan rich ; 10210 genetic center drive; san diego, CA 92121 ; 6199972348
• MDR Report Key: 21725587
• Report Number: 2024800-2025-00013
• Device Sequence Number: 3993282
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/28/2025

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: 303012
• Device Lot Number: 912178 & 908238
• 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: 03/19/2025
• Initial Report FDA Received Date: 03/28/2025
• 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