MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	APTIO AUTOMATION
Medical Device Problem Codes	Sparking (2595); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a siemens regional support center to report the observation of smoke and flames at the location on the track that housed the power cable for the centrifuge module.Siemens is investigating.
Event or Problem Description
The customer reported the observation of smoke and flames at the location on the track that housed the power cable for the centrifuge module.The power to the centrifuge module was turned off and the customer used a fire extinguisher to extinguish the flames.There are no known reports of adverse health consequences or required medical attention due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2025-00075 on 12-may-2025.Additional information 23-jun-2025: siemens evaluated this issue and provided the following conclusion.The power cable of the centrifuge module was found burnt and the cable had been coiled.The fire originated from the coiled section.The likely cause appears to be that the cable's insulation gradually deteriorated, possibly melting due to the sustained heat, eventually exposing the conductors and causing a short circuit, which led to the fire.This system is no longer under siemens warranty and is serviced by a third-party distributor.The voltage was tested and confirmed to be acceptable.After service and repair by the third-party distributor, the customer is operational.

• Brand Name: APTIO AUTOMATION SYSTEM
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): INPECO S.P.A; via givoletto 15; registration #: 3005509212; 10040 val della torre (torino) ; IT
• Manufacturer Contact: jennifer cacace ; 511 benedict ave; tarrytown, NY 10591 ; 8024302902
• MDR Report Key: 22006194
• Report Number: 2517506-2025-00075
• Device Sequence Number: 7109114
• Product Code: JJE
• UDI-Device Identifier: 00630414596754
• UDI-Public: (01)00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043546
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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 Model Number: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown