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	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed all of worklists and noted no hardware or reagent preparation issues.Suspected potential 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.Other.
Event or Problem Description
On (b)(6) 2025, customer reported 7 discrepant results using aptima hpv assay on panther fusion instruments.All 7 samples were initially run in hpv worklist 003175-20250423-02 using aptima hpv assay (ml: 911442) on panther fusion instrument (sn: (b)(6).Four samples resulted hpv positive (sample id# (b)(6), while the other 3 samples resulted hpv negative (sample id# (b)(6).Customer retested the samples in hpv worklist 002809-20250425 using aptima hpv assay (ml: 908328) on panther instrument (sn:(b)(6) and obtained discrepant results for each sample: the 4 initial hpv positive samples resulted hpv negative and the 3 initial hpv negative samples resulted hpv positive.Customer then retested the same samples again in hpv worklist 002640-20250427-11 using aptima hpv assay (ml: 911623) on panther fusion instrument (sn: (b)(6) and obtained 2 discrepant results compared to the retested results: sample id# (b)(6) retested hpv positive and sample id# (b)(6) retested hpv negative.Customer decided to report 2 of the samples (sample id# (b)(6), as hpv positive and the 5 other samples as hpv negative to physicians/patients.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: 22028618
• Report Number: 2024800-2025-00018
• Device Sequence Number: 8692100
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/15/2025

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, 911442, & 911623
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/15/2025
• 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