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	02/20/2026
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 observing a leak forming in front of the instrument.The customer reported liquid in the area of the amplified waste bin of the systems solutions drawer.There was also some crystallization observed in the system solutions drawer.The leak went onto the walking surface.It was contained and clearly marked so no one could slip.A field service engineer (fse) was dispatched.The fse found that one of the tubes coming from the bulkfill assembly had a kink and caused a backflow, hence the leak.The fse straightened the tubing and cleaned up the bulkfill and the system solutions drawer.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 kinked tubing in the system solutions drawer on an 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 february 11, 2026, prior to the leak event, the technical service bulletin (tsb) 640-079 - alinity m instrument floor liner installation was implemented on alinity m system sn (b)(6) and the alinity m system liner, pn 56-270087, was installed.Implementation of tsb 640-079 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 a kinked tubing in the system solutions drawer which caused a baclock and leak on an alinity m system, ln 08n53-02.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: 24608172
• Report Number: 3005248192-2026-00024
• Device Sequence Number: 18676402
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: (01)00884999048034(11)190820(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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2019
• 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