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	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed available logs for both initial test worklist # (b)(4) and retest worklist # (b)(4) and noted no hardware, software or contamination issues.Ts indicated that the issue was most likely due to low target or sample mishandling.Hologic completed a risk assessment.There is no product impact.Hologic has not learned of any adverse patient outcomes due to this event.
Event or Problem Description
On (b)(6) 2025, a customer reported to hologic receiving discrepant results using the aptima hpv (human papillomavirus) assay master lot 908328 on the panther instrument sn# (b)(6).Sample ids # (b)(6) were part of a cluster and initially resulted hpv positive in hpv worklist # (b)(4).Per the customer¿s lab sop, if there is a cluster of three hpv positives containing results with an s/co (signal-to-cutoff) value < 5, the samples with s/co<5 will be retested, and the retested result will be reported out.Upon retest, sample ids # (b)(6) resulted hpv negative and (b)(6) resulted hpv positive, and these results were reported out.Sample ids # (b)(6) were not retested as these samples resulted hpv positive with an s/co > 5.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: 22124857
• Report Number: 2024800-2025-00033
• Device Sequence Number: 7273495
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/02/2025

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: 908328
• 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: 05/07/2025
• Initial Report FDA Received Date: 06/02/2025
• 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