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	03/05/2026
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 that they found the top of the liquid waste bottle 2 was not sealed properly.Liquid had come out from the liquid waste tube and spread in the system solutions drawer.The customer also found liquid in the tray and on the floor.The spill had spread outside of the instrument and onto the walking path.A field service engineer (fse) was dispatched.The fse cleaned the instrument and replaced the waste bottle tubing and performed checks.The instrument was working as expected.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.
Additional Manufacturer Narrative
Investigation into this complaint included a nonconformance (nc)/capa history review, service history review, and a complaint history review.The investigation is as follows: capa / non-conformance review: a search of nc/capa records was performed for any for instances related to the user failing to connect liquid waste bottle tubing which caused a leak on the alinity m system.The query did not identify any related quality records.Service history review: the service history review found no prior service record related to the issue under investigation.The service history review found no prior service records related to the issue under investigation.On (b)(6) 2025, prior to the leak event, the technical service bulletin (tsb) (b)(4) - alinity m instrument floor liner installation was implemented on alinity m system serial number (b)(6) and the alinity m system liner, pn 56-270087, was installed.Implementation of (b)(4) and the liner installation do not prevent occurrences of leaks that spread outside the instrument footprint; however, as a mitigation, reduction in leaks beyond the instrument footprint is expected.Complaint history review: a complaint search was performed to identify past complaint tickets related to the user failing to connect liquid waste bottle tubing which caused a leak on the alinity m system, ln 08n53-002.Complaint trending was reviewed.An adverse trend was not identified for the alinity m system ln 08n53-002.Based on the results of the investigation, a product deficiency was not identified for the alinity m system, ln 08n53-002.

• 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: 24640050
• Report Number: 3005248192-2026-00027
• Device Sequence Number: 18582157
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: (01)00884999048034(11)240213(240)08N53-002
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 04/27/2026

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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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