MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. 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	09/11/2024
Type of Reportable Event	Malfunction
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.Quality control (qc) results were within expected ranges at the time of the discordant observation.The interpretation of results section of the advia centaur thcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
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 357.An elevated advia centaur cp thcg result was obtained for a 45-year-old female patient; this result was not reported to the physician.The test was repeated twice, and both repeat tests produced consistent lower results, which were accepted as correct.There are no allegations of patient harm or other adverse consequences 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.Siemens has concluded investigation, 08-oct-2024.Assay calibration and quality control (qc) results were within expected ranges at the time of the discordant measurement.It was noted that service had been performed on the associated instrument in the days just before the discordant observation.Siemens service was again dispatched to the site, but no additional work was done to the system.The customer adopted duplicate testing for thcg, to ensure no additional anomalous results were observed.Thcg performance was monitored, and no additional concerns were identified.A specific cause for the discordant result was not identified.The customer is operational, and the issue was resolved with standard 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): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 20212374
• Report Number: 1219913-2024-00405
• Device Sequence Number: 7450191
• Product Code: DHA
• UDI-Device Identifier: 00630414505152
• UDI-Public: (01)00630414505152(10)50931357(17)241209
• 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): 10/08/2024

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: 12/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 50931357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/08/2024
• Date Device Manufactured: 02/09/2024
• 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: 45 YR
• Patient Sex: Female