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

Model Number	COMMON
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On behalf of the customer, a hologic molecular applications specialist reported the customer¿s issue to technical support (ts) and relayed that the technicians were likely uncapping the aptima combo 2 (ac2) and aptima trichomonas vaginalis (atv) ready made reagent (rmr) bottles at room temperature.Customer specified that two technicians went to urgent care for pain in their right hand and received physical therapy as medical treatment.Hologic examined the retention material and found the reagents to fall within the manufacturing specifications for torque values.The customer workflow was not provided to hologic (i.E.Number of bottles the technician uncapped within a specified time period).Hologic performed a risk assessment.There are no other complaints wherein a customer indicated a strain injury uncapping these reagents.A retention check of product found reagents to fall within the manufacturing specifications for torque values.The customer has not provided further information about the technicians.
Event or Problem Description
On august 6, 2024, customer relayed to hologic that in june 2024 two technicians went to urgent care for hand/wrist pain for the right hand, allegedly caused by the uncapping of hologic ready-made-reagent (rmr) bottles.The technicians subsequently received physical therapy.

• 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: 20132104
• Report Number: 2024800-2024-00012
• Device Sequence Number: 7278047
• Product Code: LSL
• UDI-Device Identifier: 15420045514966
• UDI-Public: 15420045514966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/03/2024

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-15647
• 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: 08/06/2024
• Initial Report FDA Received Date: 09/03/2024
• 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