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

Catalog Number	ASY-11569
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the panther logs and worklists and noted there were no indications of hardware or reagent preparation issues that affected results.While the cause of the observed discrepant results is unknown, it is possible the discrepant results were due to sample mishandling or low amount of target in the sample.Hologic has not been informed of any adverse patient outcomes related to this issue.
Event or Problem Description
On february 10, 2026, customer reported that they received discrepant results on two samples while using the aptima cv/tv assay (ml 910984) on their panther instrument with serial number (sn) (b)(6).On (b)(6) 2026, customer initially tested the two samples on cv/tv worklist (wl) 002503-20260204-95 and received a trichomonas vaginalis (trich) negative result on sample id (sid) (b)(6) and a candida (c) glabrata negative result on sid (b)(6).On (b)(6) 2026, customer performed repeat tests for these samples on cvtv wl 002503-20260209-19 and received a trich positive result on sid (b)(6) and a c.Glabrata positive result on sid (b)(6).Customer then repeated all negative samples from wl 002503-20260204-95 and received two more samples with discrepant results.Sids (b)(6) both initially resulted trich negative.On (b)(6) 2026, customer performed a repeat test and received a trich positive result for sid (b)(6) on cv/tv wl 002503-20260210-14 and a trich positive result for sid (b)(6) on cv/tv wl 002503-20260210-17.Customer decided that all samples from the initial cv/tv wl 002503-20260204-95 will be resulted as indeterminate.Customer did not provide any information on the patient or patient treatment.Hologic has not been informed of any adverse patient outcomes related to this issue.
Event or Problem Description
Follow-up report.See section h11.
Additional Manufacturer Narrative
A follow-up report was created to make a correction to the 'brand name' field.Previously listed as aptima combo 2 assay and corrected to aptima cv/tv assay.

• 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: amy holtgraver ; 10210 genetic center drive; san diego, CA 92121 ; 8584108236
• MDR Report Key: 24447590
• Report Number: 2024800-2026-00008
• Device Sequence Number: 10373397
• 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,Followup
• Report Date (Section B): 06/05/2026

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: ASY-11569
• Device Lot Number: 910984
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 06/05/2026
• 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