MAUDE Adverse Event Report: UPDATE ACCORDINGLY ADVIA CENTAUR TOTAL HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

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	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated advia centaur total hcg (thcg) result which was discordant relative to repeat testing when using thcg lot 362.An initial result above reference range (for non-pregnant females) was obtained for a 37-year-old woman in fertility treatment.While the result was above cutoff, it was considered very low for a positive thcg indication.This result was not released, and the test was repeated on the same instrument.The repeat test produced a much lower result, which was considered consistent with patient clinical condition and accepted as correct.There are no allegations of any adverse patient effects in association with the observed discordance.
Additional Manufacturer Narrative
A united states customer reported observation of an elevated advia centaur total hcg (thcg) result which was discordant relative to repeat testing.No issues were identified for any other samples.No problems were identified with assay quality control (qc) or calibration, and it was noted that daily instrument maintenance was performed prior to the discordant run, and monthly maintenance had been recently completed.Siemens is investigating.
Additional Manufacturer Narrative
A customer from the united states reported observation of an elevated advia centaur total hcg (thcg) result which was discordant relative to repeat testing.Mdr 1219913-2025-00058 was initially submitted on 25-mar-2025.Update on 25-apr-2025: siemens has concluded the investigation.An initial elevated result was discordant relative to a repeat test run on the same instrument.No issues were reported for any other patient samples, and quality control (qc) results were within acceptable ranges at the time.Following this observation, siemens service was dispatched to inspect and service the instrument.A comprehensive on-site service was performed, and the customer verified assay performance following the service visit.A specific cause for the isolated elevated result was not identified, but no systemic product problem was identified.The reported issue was resolved by standard troubleshooting and service actions.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR TOTAL HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): UPDATE ACCORDINGLY; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 21686582
• Report Number: 1219913-2025-00058
• Device Sequence Number: 9420137
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)60174362(17)250906
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/28/2025

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: 09/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 60174362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: 37 YR
• Patient Sex: Female