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

Model Number	ADVIA CENTAUR XP ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated progesterone (prge) results obtained on three patient samples on an advia centaur xp analyzer.Quality control (qc) recovered acceptably.The customer found failure in the incubation ring loading.Siemens reviewed the instrument data files and the information provided by the customer and found that the pre-light ratio test was failed.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit the cse, inspected the analyzer and replaced the cuvette presence sensor, performed emptying/filling tests of the ring which, passed.Then, the cse, performed daily maintenance and found that in the manifold area of the washing station (wash probe1, wash probe2, wash probe3, and wash probe4), the cuvettes were overflowing and spilling onto the base of the ring and also found overflow in the drains of all reagent probes (reagent probe1, reagent probe2, reagent probe3, reagent probe auxiliary).Further, the cse, disassembled the entire washing station manifold and luminometer to dry the entire path that had liquid spilled from the overflowing cuvettes, performed an analysis of the vacuum circuit, and found an obstruction in pipe 1, which supplies vacuum to the internal waste reservoir, cleared the obstruction, by cleaning pipe 1, the reservoirs lid, and hydraulic connector.Next the cse, performed a daily maintenance which passed and ran qc which was acceptable.Siemens further evaluated the event and concluded that the blockage in the vacuum line leading to improper aspiration of fluids potentially contributed to this event.The customer is operational.The instrument is performing according to specifications.No further evaluation is required.
Event or Problem Description
The customer reported that they obtained erroneously elevated progesterone (prge) results on three patient samples on an advia centaur xp analyzer.The erroneous results were reported to the physician(s).The samples were repeated on an alternate advia centaur xp analyzer.The repeat results obtained were consistent with the patient¿s clinical history and considered correct.The repeat results were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated prge results.

• Brand Name: ADVIA CENTAUR XP ANALYZER
• Common Device Name: ADVIA CENTAUR XP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; registration number: 8020888; chapel lane, swords,; co. dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24763832
• Report Number: 2432235-2026-00087
• Device Sequence Number: 15769886
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: ADVIA CENTAUR XP ANALYZER
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/02/2026
• 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