MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP INSTRUMENT

Model Number	ADVIA CENTAUR XP INSTRUMENT
Medical Device Problem Codes	Leak/Splash (1354); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that they heard a loud noise and observed smoke from the advia centaur xp instrument.The customer immediately unplugged the instrument and noticed a leak from the reagent compartment and underneath the left side of the instrument.With siemens remote assistance, the customer verified the instrument and noticed power surge, burnt power outlet, melted outlet and broken prongs.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, noticed that a short circuit had occurred in the main power inlet and power cord.The cse replaced the power cord and verified the circuits for any shorts or damage.Additionally, the cse fixed the leak from the pressurized manifold area in the reagent fluidics drawer.The instrument was then powered up and quality controls (qcs) were processed, which recovered within the acceptable range.Siemens further evaluated the event and determine that the short circuit caused by a water leak potentially contributed to this event.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer heard a loud noise and observed smoke from an advia centaur xp instrument.The customer stated that they immediately unplugged the instrument and noticed a leak from the reagent compartment and underneath the left side of the instrument.There were no injuries reported.There are no known reports of adverse health consequences due to this event.

• Brand Name: ADVIA CENTAUR XP INSTRUMENT
• Common Device Name: ADVIA CENTAUR XP INSTRUMENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23049352
• Report Number: 2432235-2025-00237
• Device Sequence Number: 13178025
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K041133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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: ADVIA CENTAUR XP INSTRUMENT
• Device Catalogue Number: 10364455
• 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: 08/22/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2012
• 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