MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. TOTAL HCG (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	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported observation of an elevated advia centaur total hcg (thcg) result which was discordant relative to repeat testing.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 evaluating the event.
Event or Problem Description
The customer reports observation of an elevated advia centaur total hcg (thcg) result with lot#: 361 which was discordant relative to repeat testing.An initial elevated result was obtained for the patient in question.This result was reported to the physician, who questioned the result.The same sample was repeated on the original analyzer and obtained a lower result which was considered correct.A corrected report was issued based on repeat testing.There is no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2025-00032 on 04-feb-2025.Additional information (06-mar-2025): siemens healthcare diagnostics has concluded the investigation of the event.Siemens evaluated the instrument data, and the information provided by the customer.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse decontaminated the system, replaced the wash separation manifold, acid and base pumps, reagent probes 1 and 2, luminometer, vacuum regulator and waste reservoir bottle tubing/cap.Advia centaur xp thcg assay performance was monitored following these service actions and it remains acceptable.Siemens further evaluated the event and concluded that the issue with vacuum which was resolved by replacing the vacuum regulator and performing service actions, potentially contributed to the elevated thcg result.The reagent and instrument are performing according to specifications.The customer is operational, and no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• Brand Name: TOTAL HCG (THCG)
• Common Device Name: TOTAL HCG (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: 21302037
• Report Number: 1219913-2025-00032
• Device Sequence Number: 15474789
• Product Code: DHA
• UDI-Device Identifier: 00630414505183
• UDI-Public: (01)00630414505183(10)25405361(17)250526
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 03/28/2025

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: 10331723
• Device Lot Number: 25405361
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/28/2025
• 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: 34 YR
• Patient Sex: Female