MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA URINE SPECIMEN COLLECTION KIT FOR MALE AND FEMALE URINE SPECIMENS; DNA-REAGENTS, NEISSERIA

Catalog Number	301040-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a customer in canada contacted hologic to report ergonomic concerns on their operators.On (b)(6) 2026, hologic received clarification that three operators at the customer site sustained ergonomic injuries due to specimen rack handling on the instrument, adding and/or removing sample tubes, and capping or uncapping specimen tubes.The injuries reported included tingling and numbness in the hands, pain in the elbow, and a hand injury.Due to these injuries, the operators were unable to perform some of these lab tasks.The customer reported the injuries internally to the injury near miss (inm) shared health and externally to the workers¿ compensation board (wcb).The customer did not provide further details about the injuries, any medical intervention or the medical status of the injured operators.
Additional Manufacturer Narrative
The average testing throughput for this customer site is approximate 500 ¿ 700 samples per day based on average aptima specimen tubes.As of (b)(6) 2026, the customer did not verify whether medical prevention was provided or the medical status of the injured operators.The panther/ panther fusion system operator¿s manual recommends, ¿to reduce the risk of developing stress injuries, take frequent breaks from repetitive tasks like opening and closing tubes.¿ repetitive strain injuries (rsis) are related to multiple factors including workstation set ups, multiple jobs performed by one operator, activities outside of work, or general susceptibility profiles of individuals.H3 other text : other.

• Brand Name: APTIMA URINE SPECIMEN COLLECTION KIT FOR MALE AND FEMALE URINE SPECIMENS
• Common Device Name: DNA-REAGENTS, NEISSERIA
• 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: 25522051
• Report Number: 2024800-2026-00034
• Device Sequence Number: 16090298
• Product Code: LSL
• UDI-Device Identifier: 25420045506265
• UDI-Public: 25420045506265
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111409
• 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): 06/16/2026

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: 301040-01
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/16/2026
• 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