MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR TOTAL HCG (THCG); 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	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained elevated advia centaur xp total hcg (thcg), lot 361, results on 2 samples from the same patient that were discordant relative to retest results.The initial results were reported to the physician and were questioned.The samples were retested in duplicate on the same instrument/day and results were lower as expected.Corrected reports were issued.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
The us customer reported an observation of elevated advia centaur xp total hcg (thcg) lot 361 results on 2 samples from the same patient that were discordant relative to lower retest results on the same instrument/day.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.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2025-00020 initial report on 15-jan-2025.Siemens investigated a customer report of elevated advia centaur xp total hcg (thcg) lot 361 results on 2 samples from the same patient that were discordant relative to lower results obtained when the same samples were retested on the same instrument.Customer service engineer (cse) was dispatched to the account and performed routine instrument troubleshooting that included replacement of the wash manifold and sample syringe.Advia centaur xp thcg assay performance was monitored following these service actions and it remains acceptable.The customer is operational, the reported issue was resolved by standard troubleshooting and service actions.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR TOTAL HCG (THCG)
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 21158678
• Report Number: 1219913-2025-00020
• Device Sequence Number: 12870158
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)19599361(17)250526
• Combination Product (Y/N): N
• 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): Unknown
• 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): 02/05/2025

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: 19599361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/04/2025
• 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 Sex: Unknown