MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M SYSTEM; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Catalog 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	02/26/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported a leak on their alinity m system.The customer reported an instrument leak of vapor barrier on their alinity m instrument.Liquid had left the footprint of the instrument.The customer turned off the instrument and cleaned the walking area while wearing appropriate personal protective equipment (ppe).A field service engineer (fse) was dispatched.The fse found a leaking vapor barrier reservoir and replaced it.There was no report of injury or any actual exposure to the leaked liquid.There was no patient involved as the leak was identified by the alinity m system user.

• 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 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 24558285
• Report Number: 3005248192-2026-00023
• Device Sequence Number: 8860571
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: (01)00884999048034(11)191219(240)08N53-002
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/22/2026

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 Catalogue Number: 08N53-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2019
• 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