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	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported error messages 5209 (sample z2 mtr comm bad state) and zip 5v supply overload on the alinity s system.No fire or smoke was observed.The ambassador inspected the instrument and noticed a blackened cable in the cicoil cable to the z2 motor.Additionally, the meridian controllers on 6-axis boards were blinking red.The ambassador replaced the damaged sample 2 cicoil cable, resolving the issue.No impact to patient management or user safety was reported.
Additional Manufacturer Narrative
The abbott ambassador performed instrument troubleshooting and noticed a dark discoloration on a cicoil cable.The blackening of a cable in the s-r1 cicoil cable was limited to the cicoil and did not spread to other parts on the instrument.The cable was replaced, and the instrument functioned as intended.An instrument service history review for (b)(6) did not identify any additional instances or contributing factors to the current complaint.A review of complaint and trending data for the s-r1 cicoil cable and the alinity s system regarding the issue did not identify an increase in complaint activity.The device history record was reviewed and did not identify any non-conformances, potential non-conformances or deviations related to the issue described in the current complaint.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity s system, serial number (b)(6), or the s-r1 cicoil cable was 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: 21337015
• Report Number: 1628664-2025-00001
• Device Sequence Number: 12869723
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/07/2025

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): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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