MAUDE Adverse Event Report: HOLOGIC, INC. TOMCAT INSTRUMENT; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Catalog Number	ASY-07379
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of (b)(6) 2026, the customer has not submitted any logs for hologic review and has not confirmed whether any of the affected patient samples were repeat tested, or how results were reported/ amended.Further, the customer has not reported any additional issues with their tomcat instrument after service.Hologic has not been informed of any adverse patient outcomes related to this event.
Event or Problem Description
On (b)(6) 2026, a customer reported contamination from the tomcat instrument (sn: (b)(6).The customer noticed multiple samples aliquoted from the tomcat returned with a higher prevalence of trichomonas vaginalis positive results.The customer observed that the tomcat pipette tips left a ¿dragging¿ trail of dried liquid, the pipettor motion/ movement appeared inconsistent and there were no instrument errors due to this issue.The customer agreed to put the result reporting on hold and not to use the tomcat instrument until service was performed.On (b)(6) 2026, a hologic field service engineer (fse) went onsite and confirmed customer¿s observation.Fse serviced the instrument.The instrument passed verification testing and was confirmed operational before being released back to the customer for use.

• Brand Name: TOMCAT INSTRUMENT
• Common Device Name: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• 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: maria osorio ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 25021262
• Report Number: 2024800-2026-00020
• Device Sequence Number: 10450759
• Product Code: JQW
• UDI-Device Identifier: 15420045504677
• UDI-Public: 15420045504677
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASY-07379
• 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: 03/29/2026
• Initial Report FDA Received Date: 04/28/2026
• 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
• Patient Sex: Unknown