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	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called to report a diluent leak on their alinity m system.Customer loaded a new diluent bottle in the morning and it started leaking out of the bottom of the analyzer under the solutions drawer (outside of the footprint).Customer then performed a shutdown and startup and has since been getting system solution (diluent) transfer errors.Leakage occurred right when the transfer should have happened; the diluent seemed to be going straight from the bottle to the floor.Customer cleaned the floor wearing protective gear at all times.No accident or injury occurred.Customer was not able to provide pictures as they had cleaned the leakage prior to calling the ticket in.The customer stated that the volume of leaked liquid was large; leak was substantial on the bottom inside the instrument, but also leaked outside the footprint of the instrument onto the walkway where they had to use tissues to soak it up.Field service engineer visit confirmed that the float sensor failed.Float sensor was replaced per the service manual and was confirmed to be reading correctly.There was no patient involved as the leak was identified by the alinity m system user.
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.
Additional Manufacturer Narrative
Investigation into this complaint included service history review, quality data review and a complaint history review.The results of the investigation are summarized as follows: service history review: the service history review found one (1) prior service record related to the issue under investigation.Review also indicates that on june 18, 2025, prior to the leak event, technical service bulletin (tsb) 640-079 - alinity m instrument floor liner installation was implemented on alinity m system sn (b)(6).The alinity m system liner, pn 56-270087, was installed underneath the alinity m system and designed to mitigate the occurrences of leaks that spread beyond the instrument footprint.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.Quality data review: nonconformance (nc)/corrective action preventive action (capa) search a search of nc/capa records was performed for instances related to a leak due to a faulty diluent reservoir sensor, pn 56-190088-02, on an alinity m system, ln 08n53-02, as documented in the complaint ticket under review in this investigation.The query did not find any quality record (qr) related to a leak due to a faulty diluent reservoir sensor, on the alinity m system, ln 08n53-02.Complaint history review a complaint search was performed to identify past complaint tickets for instances related to a leak due to faulty diluent reservoir sensor, pn 56-190088-02, on an alinity m system, ln 08n53-02.Additionally, complaint trending was reviewed.An adverse trend was not identified for the alinity m system (base list number 08n53), which includes the reservoir sensor, single tube, pn 56-190088-02.A review of spare part trending was also performed.No unexplained shift in quality data was identified.Based on the results of the investigation, a product deficiency was not identified for the alinity m system, ln 08n53-02 or reservoir sensor, single tube, pn 56-190088-02.

• 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: 24284397
• Report Number: 3005248192-2026-00016
• Device Sequence Number: 8569632
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: (01)00884999048034(11)210228(240)08N53-002
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 03/27/2026

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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2021
• 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