MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR; ADVIA CENTAUR INTACT PARATHYROID HORMONE (PTH) ASSAY

Catalog Number	10699154
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated intact parathyroid hormone (pth) result on a patient sample on an advia centaur xpt analyzer.Siemens evaluated the instrument data and the information provided by the customer.Quality control (qc) recovered acceptably.As per advia centaur pth instructions for use (ifu), interpretation of results: results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.Limitation: patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize the interference from heterophilic antibodies.The customer investigated the sample for heterophilic antibodies and found a heterophilic antibody interference.Reagent and analyzer problems were ruled out as cause of elevated result because no qc issue reported and no other patient samples were affected.Based on the available information, the cause of the elevated results is heterophilic antibody interference.The customer is operational.The device is performing according to specifications.No further evaluation is required.A separate mdr was filled to address the erroneous results obtained on (b)(6) 2025.
Event or Problem Description
The customer reported that they obtained erroneously elevated intact parathyroid hormone (pth) results on a patient sample on an advia centaur xpt analyzer.On (b)(6) 2025, the erroneous result was reported to the physician(s) and was questioned.The same sample was retested twice on the original advia centaur xpt analyzer and obtained the elevated results same as initial result.The sample was retested on an alternate non-siemens analyzer, and a lower result was obtained consistent with the patient's clinical history.The sample was treated with heterophilic antibody blocking reagent and retested on an alternate non-siemens analyzer and a lower result was obtained and considered correct.A corrected report was issued.The customer investigated the sample for heterophilic antibodies and found a heterophilic antibody interference.Then, the customer treated the sample with heterophilic antibody blocking reagent and retested which gave acceptable results.On (b)(6) 2025, the same sample was processed on the original advia centaur xpt analyzer and elevated result was obtained considered erroneous.The sample was treated with heterophilic antibody blocking reagent and retested on the original advia centaur xpt analyzer and a lower result was obtained compared to the initial elevated result.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ADVIA CENTAUR
• Common Device Name: ADVIA CENTAUR INTACT PARATHYROID HORMONE (PTH) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1219913; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23322835
• Report Number: 1219913-2025-00189
• Device Sequence Number: 21316719
• Product Code: CEW
• UDI-Device Identifier: 00630414592336
• UDI-Public: (01)00630414592336(10)44422109(17)260713
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163658
• 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): 10/17/2025

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 Expiration Date: 07/13/2026
• Device Catalogue Number: 10699154
• Device Lot Number: 44422109
• 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: 09/22/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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: Female