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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur total hcg (thcg) patient result (auto-diluted) which was discordant relative to repeat testing (manually diluted) and alternate method testing.Siemens is evaluating the event.
Event or Problem Description
The customer reported observation of an elevated advia centaur total hcg (thcg) patient result (auto diluted) which was discordant relative to repeat testing (manually diluted) and alternate method testing when using lot 363.An initial above assay range result was obtained for the patient sample in question.The sample was auto-diluted (1:200) and retested, yielding a significantly higher result.This result was considered discordant and was not reported to the physician.The sample was subsequently auto diluted (1:10), which obtained a lower result.The sample was then retested using manual dilution (1:20), which produced a similar lower result.None of these results were reported to the physician(s).Instead, the sample was sent to an alternate laboratory and tested using an alternate method (vidas), which yielded a lower result.The lower results were considered correct and the lower result obtained on the alternate method was reported to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2025-00219 was initially filed on 15-dec-2025.Additional information (18-mar-2026): siemens has concluded the investigation for the customer complaint of observation of an elevated advia centaur total hcg (thcg) patient result (auto-diluted) which was discordant relative to repeat testing (manually diluted) and alternate method testing.Siemens evaluated the instrument data, the information provided by the customer, and the instrument performance, which included the siemens customer service engineer (cse) total service visit.Cse verified alignment of the sample and reagent probes, adjusted the reagent probe dilutor, inspected the peristaltic pump tubing, evaluated the wash blocks, and performed decontamination of the acid and base systems.Following this routine troubleshooting intervention, quality control (qc) results recovered acceptably, and no issues were reported with other patient samples.Based on the available information, a specific cause for the discordant results was unable to be determined.The issue was resolved by routine troubleshooting; a product problem was not identified.Customer is operational; no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR
• Common Device Name: ADVIA CENTAUR THCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.SIEMENS HEALTHCARE DIAGNO; 333 coney st.; registration #: 1219913; 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: 23801777
• Report Number: 1219913-2025-00219
• Device Sequence Number: 9359965
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)90851363(17)251124
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K200210
• 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): 04/14/2026

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 Expiration Date: 11/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 90851363
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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: Unknown