MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	N/A
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens and reported the observation of smoke for the immulite 2000xpi, serial number (b)(6).A customer service engineer (cse) went on site and checked ac power distribution board's 5 fuses and found one that is open.The cse replaced the broken fuse.He turned on ups and measured voltage and it is at 219.9v.The cse made sure transformer is set to 220v.He turned on instrument and ups beeps stating that load short-circuited.Ups also did an auto shot downed.He was unable to read test points on other boards due to instrument does not have any power because ups shutdown.Siemens continues to investigate.
Event or Problem Description
The customer contacted siemens and reported the observation of smoke, smell of smoke for the immulite 2000xpi, serial number (b)(6).There were no reports of injuries related to this event.
Additional Manufacturer Narrative
Siemens healthineers filed initial mdr 2432235-2026-00074 on 2026-03-11.Additional information received on 2026-03-20: siemens healthineers reviewed the information provided and data obtained.Siemens healthineers replaced the transformer, dc (direct current) power supply, ups (uninterruptible power supply), and damaged luminometer components.The customer is operational and the behavior resolved via routine troubleshooting.The instrument is performing according to specifications.No further evaluation of this device is required.Section h6 has been updated to reflect updated investigation findings and investigation conclusion codes and component code.

• Brand Name: IMMULITE 2000 XPI
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07936
• Manufacturer Contact: bernd schick ; emil-von-behring- str. 76; marburg 35041 ; GM 35041 ; 91734802864
• MDR Report Key: 24566998
• Report Number: 2432235-2026-00074
• Device Sequence Number: 8355697
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: (01)00630414945422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970227
• 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,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 Model Number: N/A
• Device Catalogue Number: 10373214
• Device Lot Number: N/A
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown