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

Catalog Number	303570
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed both worklists and noted no hardware or reagent preparation issues.Ts noted that the samples were either mishandled or were true 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 situation.
Event or Problem Description
On (b)(6) 2025, customer reported a discrepant result using aptima hpv screening assay (ml 905627), worklist: (b)(4), on panther plus instrument serial number: (b)(6).Customer noted the sample was ran in duplicate on the same worklist and produced both a negative and positive result.Customer retested the same sample using worklist: (b)(4) on panther instrument serial number: (b)(6) and obtained a negative result.Customer noted that they would report the negative result to the patient.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: 21289082
• Report Number: 2024800-2025-00006
• Device Sequence Number: 18119957
• 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): 01/31/2025

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: 303570
• Device Lot Number: 905627
• 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: 01/16/2025
• Initial Report FDA Received Date: 01/31/2025
• 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