MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA CV/TV ASSAY; VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM

Catalog Number	PRD-05189
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
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.Ts suspected potential sample mishandling or low target samples.Hologic performed a risk assessment and noted no product impact.Ts informed the customer that results from different samples cannot be compared as they are separate collections.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 that they received a discrepant result using aptima cv/tv assay master lot 913344 when testing samples on panther fusion plus instruments.On (b)(6) 2025, two samples from the same patient were tested on cv/tv wl-003679-20250711-09 on panther fusion plus instrument serial number (b)(6) and sample sid (b)(6) resulted cv negative / tv positive while sample sid (b)(6) resulted cv negative / tv negative.Customer reported both results to the physician/patient.On (b)(6) 2025, both samples were retested on cv/tv wl-004306-20250716-08 on panther fusion plus instrument serial number (b)(6).Sample sid (b)(6) resulted cv negative / tc positive again but sample sid (b)(6) resulted cv negative / tv positive.On the same day the customer retested sid (b)(6) one more time on cv/tv wl-004304-20250716-03 on panther fusion plus instrument serial number (b)(6) and resulted cv negative / tv positive again.Customer noted they would amend the sid (b)(6) result to cv negative / tv positive.Customer did not have any information related to patient treatment.Hologic has not learned of any adverse patient outcomes due to this event.

• Brand Name: APTIMA CV/TV ASSAY
• Common Device Name: VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• 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: 22799343
• Report Number: 2024800-2025-00052
• Device Sequence Number: 18270742
• Product Code: PQA
• UDI-Device Identifier: 15420045512061
• UDI-Public: 15420045512061
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190472
• 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): 08/13/2025

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: PRD-05189
• Device Lot Number: 913344
• 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: 07/17/2025
• Initial Report FDA Received Date: 08/13/2025
• 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