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

Catalog Number	10308985
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an elevated advia centaur total human chorionic gonadotropin (thcg) patient result which was discordant relative to repeat testing.Siemens reviewed the instrument data, and the information provided by the customer.Quality control (qc) recovered within the acceptable ranges and no issues were reported with other patient samples.The sample carryover was ruled out as the analyzer uses disposable sample tips.Based on the available information, the cause of the discordant result was unable to be determined.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.
Event or Problem Description
The customer reported that they obtained an erroneously elevated advia centaur total human chorionic gonadotropin (thcg) patient result vs repeat testing.After a week from the date of event the patient was redrawn and processed on the original analyzer, and the result was lower and consistent with the patient's clinical history.The new sample result was reported to the physician(s) and physician(s) questioned the initial elevated result.The original sample was repeated again on the original analyzer and the result obtained was lower and consistent with the new sample 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 THCG
• 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: 23529784
• Report Number: 1219913-2025-00205
• Device Sequence Number: 9020786
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)96921366(17)260718
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: 07/18/2026
• Device Catalogue Number: 10308985
• Device Lot Number: 96921366
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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