MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Codes	Smoking (1585); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported a rattling or grinding noise, a burning smell, and observed smoke from underneath the top cover of an atellica im 1300 analyzer.Before the customer service engineer (cse) visit, the customer turned off the analyzer, grabbed fire extinguisher, and opened the front of the analyzer.The customer stated that after powering off, the excessive heat and the smoke stopped.There was no smoke or fire alarm activated within the laboratory.A siemens cse was dispatched to the customer¿s site.During the visit, the cse booted the analyzer and observed grinding from the wash ring heater fan assembly.Then, the cse unplugged the heater, initialized the rest of the analyzer, ran auto check, which passed, inspected the analyzer, and observed no other sources of heat or smoke.Next, the cse replaced the wash ring heater and fan.Siemens evaluated the event and determined that malfunctioned heater fan assembly and the fan, which was unable to turn, potentially contributed to the reported event.The analyzer is performing according to specifications.No further evaluation is required.
Event or Problem Description
The customer reported that the temperatures for an atellica im 1300 analyzer were not coming within the range.As a result, the customer restarted the analyzer from the breaker.After the restart, the customer heard a rattling or grinding noise, smelled a burning smell, and observed smoke from underneath the top cover of the analyzer.The smoke was coming from an area near luminometer.There were no leaks or visible flames.No one was injured, and no medical intervention was required due to this event.There are no known reports of adverse health consequences due to the reported event.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Common Device Name: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24091342
• Report Number: 2432235-2026-00011
• Device Sequence Number: 10469130
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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 Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• 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: 12/23/2025
• Initial Report FDA Received Date: 01/16/2026
• 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