MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported instrument error 5600-b317 (¿sample pipettor gantry failed¿) on the alinity s system.The field service representative determined that the 6-axis board was damaged, likely due to liquid leaking onto the board.This leak also caused damage to sample meridian boards 1¿3 and resulted in a blown fuse and charring on both the meridian board and the 6-axis board consistent with liquid exposure.There was no impact to patient management or user safety reported.
Additional Manufacturer Narrative
The alnty pptr probes (part number 03r96-02), integrated servo controller (part number b-30111055-03), and pcb assy, 6 axis servo backplane (part number b-90000675-02) were replaced and the unit functioned as intended on the alinity s system, serial number (b)(6).A review of the instrument service history identified no contributing factors to the current complaint.A review of tracking and trending data associated with integrated servo controller and the pcb assy, 6 axis servo backplane, and alnty pptr probes, did not identify any trends.A review of tracking and trending did not identify any trends for the alinity s system with regards to the customer reported event.A review in the corrective action and preventive actions (capa) system did not identify any related nonconformances, potential nonconformances, or deviations for integrated servo controller and the pcb assy, 6 axis servo backplane, and alnty pptr probes, associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the alinity s system for serial (b)(6), the integrated servo controller (part number b-30111055-03), the pcb assy, 6 axis servo backplane (part number b-90000675-02), or alnty pptr probes (part number 03r96-02) were identified.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24278137
• Report Number: 1628664-2026-00002
• Device Sequence Number: 9962595
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: BL125674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 06P16-01
• 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: 01/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• 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