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

Catalog Number	08N53-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A field service engineer (fse) reported a face splash event.The fse reported while they were working on the system solution drawer on the alinity m system, the tube on waste line 1 disconnected and some sprayed on their face.The immediate action was to wash the impacted area with water.Fse was wearing personal protective equipment (ppe).After that, the fse went to the emergency department and in conversation with the infectious disease specialist decided to prescribe them an antiviral.Fse will receive control in 30 days.
Additional Manufacturer Narrative
An investigation is in process.A follow-up report will be submitted when the investigation is complete.This incident is being reported to fda because the incident occurred internationally using the alinity m system, list 08n53-002, which is also us fda approved.

• 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 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: 50380402
• Report Number: 3005248192-2026-00076
• Device Sequence Number: 15946301
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: (01)00884999048034(11)201012(240)08N53-002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue 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: Not provided
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown