MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIACGNOSTICS, 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	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an elevated advia centaur xpt total hcg (thcg) patient result that was discordant relative to retesting.The initial elevated result was reported and questioned by the physician.The sample was retested in duplicate and the results were lower.A corrected report was issued with the lower results.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens investigated a united states customer report of an elevated advia centaur xpt total hcg (thcg), lot: 361, patient result that was discordant relative to retesting.The patient sample initially resulted 95 miu/ml.The sample was repeated twice later in the day and both results were <1 miu/ml.The lower results were considered correct.Quality control (qc) recovered within acceptable ranges and no issues were reported with other patient samples.The customer received a sample probe tip detection error on the instrument immediately after the discordant result was generated.The error stopped the system from processing samples.While troubleshooting, the customer found several jammed sample tips containing serum near the sample tip orientation chute.This could potentially cause sample contamination.The customer homed the system multiple times and was able to resume running.The system continued to run with jammed sample tips until they were later removed.Service was dispatched to inspect the instrument for this event.A total service call was performed, but no instrument issues were identified at that time.The engineer ran multiple replicates of a negative sample, and all values resulted <1 miu/ml.The customer is operational, and the reported issue was resolved by routine troubleshooting.

• Brand Name: ADVIA CENTAUR TOTAL HCG (THCG)
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIACGNOSTICS, 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: 20817330
• Report Number: 1219913-2024-00484
• Device Sequence Number: 15632473
• 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): 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): 12/02/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/02/2024
• 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