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	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a customer reported to hologic that they received discrepant results using aptima cv/tv assay master lot: 907460 and aptima trichomonas vaginalis assay master lot: 904910 on the panther instrument.Sample ids#: (b)(6) were part of a cluster of five positive tests, initially detected as tv positive using the aptima cv/tv assay.The customer questioned these results and retested the cluster of five positive samples.Upon retest, sample ids#: (b)(6) resulted tv negative using aptima trichomonas vaginalis assay.Hologic technical support (ts) made three attempts to contact the customer to determine if the results were reported to either the physician or the patient but was unable to reach the customer.No patient treatment information was provided by the customer.Hologic has not learned of any adverse patient outcomes due to this event.
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 or software issues.Ts) made three attempts to contact the customer for further information and logs but was unable to reach them.Ts was unable to review the fluorescent curves because the customer did not provide the logs containing this information.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: katrina tarroja ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 21323284
• Report Number: 2024800-2025-00007
• Device Sequence Number: 8697019
• Product Code: PQA
• UDI-Device Identifier: 15420045512061
• UDI-Public: 15420045512061
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/06/2025

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: 907460
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• 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