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	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed all of customer worklists and noted no hardware or reagent preparation issues.Hologic determined the most likely cause of the discrepant hpv result is potential sample mishandling or 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 using aptima hpv assay master lot 915392 when testing a sample on panther instrument serial number (b)(6).On (b)(6) 2025, sample sid (b)(6) was tested on hpv (b)(4) and resulted hpv negative with an s/co value of 0.00.Customer reported this result to the physician/patient.Customer noted that this sample was accidentally left on the instrument and run again on the same worklist the next day.On (b)(6) 2025, sample sid (b)(6) resulted hpv positive with an s/co value of 5.26.On (b)(6) 2025, the same sample was retested on hpv (b)(4) and resulted hpv positive again with an s/co value of 5.97.Customer noted that all 3 tests were performed with the same sample tube.The result was amended to indeterminate and customer requested for a new sample to be recollected.Customer was not aware of any patient treatment.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: geovan rich ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 22925711
• Report Number: 2024800-2025-00059
• Device Sequence Number: 18450589
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/29/2025

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: 915392
• 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: 08/13/2025
• Initial Report FDA Received Date: 08/29/2025
• 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