MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer from outside the united states (ous) reported observation of an erroneously elevated total human chorionic gonadotropin (thcg) result obtained on a patient sample on an advia centaur xpt system.Quality control (qc) recovered within the lab ranges.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating the event.
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated total human chorionic gonadotropin (thcg) result on a patient sample on an advia centaur xpt system.The erroneously elevated result was reported to the physician and was questioned.The same sample was reprocessed on the same advia centaur xpt system.The reprocessed result was lower and matched the patient¿s clinical picture.The lower result was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated total human chorionic gonadotropin (thcg) result.
Additional Manufacturer Narrative
Mdr 1219913-2025-00056 was initially filed on 21-mar-2025.Additional information (28-mar-2025): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states (ous) reported observation of an erroneously elevated total human chorionic gonadotropin (thcg) result on a patient sample on an advia centaur xpt system.Siemens evaluated the instrument data and the information provided by the customer.Reagent and instrument issues were ruled out based on the review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Based on the available information, the specific cause of the erroneous result cannot be determined.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR THCG
• 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.; 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: 21661672
• Report Number: 1219913-2025-00056
• Device Sequence Number: 8647424
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)029361(17)250526
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/17/2025

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: 05/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 029361
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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 Age: 35 YR
• Patient Sex: Female