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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that two falsely elevated enhanced estradiol (ee2) results, obtained on the advia centaur xp instrument, were reported to the physician(s).Siemens dispatched a customer service engineer (cse) to the customer site.Siemens retrieved instrument and test data and noted that the calibration was within the acceptability criteria, and daily controls were within the expected ranges, as reported by the customer.The cse performed preventive maintenance and services, which included cleaning and visual inspection of the luminometer, wash block, sample syringe, alignment of all needles, wash area, vacuum line, and no issue was noted.Additional inspections were performed.The cse noted that the wash block reagent probe # 3 (rp3) tubing was partially bent.The cse performed replacement of the three-reagent needle tubing, auxiliary needle tubing, bubble sensor, and the acrylic wash tubing assembly.The instrument was verified and is operating as specified.Siemens is investigating the event.
Event or Problem Description
The customer reported that two falsely elevated enhanced estradiol (ee2) results, obtained on the advia centaur xp instrument, were reported to the physician(s).The customer used an alternate advia centaur xp instrument and the same samples to perform repeat testing.The repeat results were lower, considered correct, and the customer issued corrected reports.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The initial mdr 2432235-2025-00226 was filed on 28-aug-2025.Additional information (15-sep-2025): the customer informed siemens that services performed by the customer service engineer (cse) have improved the enhanced estradiol (ee2) assay performance.The customer has not observed problems with ee2 or other assays.Siemens confirmed that the ee2 lot 127105 calibration was valid, and bio-rad lyphocheck quality control (qc) lot 40460 was within expected ranges before running patient samples.Siemens evaluated the service performed, which included replacing the reagent and ancillary probe tubing, bubble sensor, acrylic wash block tubing, diluter head of reagent probe 2 syringe, and concluded that the cause of falsely elevated enhanced estradiol (ee2) results is unknown based on the servicing of multiple parts.The advia centaur xp instrument is operating as specified, and no further evaluation is required.Siemens updated section h6 to include new codes that reflect the investigation conclusion.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; registration number: 8020888; swords, co., dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 22916988
• Report Number: 2432235-2025-00226
• Device Sequence Number: 9783573
• 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,Followup
• Report Date (Section B): 09/24/2025

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
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2013
• 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