MAUDE Adverse Event Report: Abbott Molecular, Inc. Alinity m System; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Model Number	08N53-002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• Brand Name: Alinity m System
• Common Device Name: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• Manufacturer (Section D): Abbott Molecular, Inc.; 1300 e. touhy ave.; des plaines IL 60018 -331
• Manufacturer (Section G): Abbott Molecular, Inc.; 1300 e. touhy ave.; des plaines IL 60018 -331
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018--331 ; +1(224)206-4064
• MDR Report Key: 50308460
• Report Number: 3005248192-2026-00075
• Device Sequence Number: 16127635
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: (01)00884999048034(11)201025(240)08N53-002
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: 08N53-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown