MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA COMBO 2 ASSAY; DNA-REAGENTS, NEISSERIA

Model Number	COMMON
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A customer provided feedback on the tightness of the caps of the hologic ac2 ready-made-reagent (rmr) bottles.Technicians open approximately 6-14 kits a day and after the 6th kit, it hurts their hands.Customer claimed they could not open the bottles and will order bottle openers for their lab.Hologic inquired into the customer¿s report of pain to see if any technician had to seek treatment.Customer relayed that one technician reported wrist strain on (b)(6) 2024, and returned to full work activity in (b)(6) 2024.As of (b)(6) 2024, this technician was still undergoing medical checks every two weeks.Hologic performed a risk assessment.There has been one prior instance of a customer reporting medical treatment allegedly needed because of uncapping rmr product.Hologic examined retention materials and found the reagents to fall within the manufacturing specification for torque values.
Event or Problem Description
On october 9, 2024, customer relayed to hologic that technicians had hurt their hands, allegedly by uncapping of hologic ac2 ready-made-reagent (rmr) bottles.Upon further inquiry, hologic became aware that a technician had reported wrist strain on (b)(6) 2024, and was not able to return to full work activity until (b)(6) 2024.As of (b)(6)2024, the technician was still going through medical checks every two weeks.

• Brand Name: APTIMA COMBO 2 ASSAY
• 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: zachary hansen ; 10210 genetic center drive; san diego, CA 92121 ; 9519739240
• MDR Report Key: 20621111
• Report Number: 2024800-2024-00033
• Device Sequence Number: 12625826
• Product Code: LSL
• UDI-Device Identifier: 15420045514966
• UDI-Public: 15420045514966
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/06/2024

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 Model Number: COMMON
• Device Catalogue Number: ASY-15648
• 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: 10/09/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (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