MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR 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	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.Siemens reviewed the instrument data, information provided by the customer and the instrument performance which included siemens customer service engineer (cse) total service visit.No instrument issues were observed.Reagent and instrument issues were ruled out based on quality control (qc) and calibration recovery within acceptable ranges and no issues were reported with other patient samples.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.Based on the available information, the cause of the discordant result was unable to be determined and the issue was isolated to the affected patient sample.The issue was resolved by routine troubleshooting.A product problem has not been identified.Customer is operational and no further actions are required.
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 lot 363.An initial elevated result was obtained for one (1) patient sample.The initial elevated result was reported to the physician who questioned the result.Subsequently, two new samples were drawn from the affected patient and tested on the original analyzer, both of which yielded lower results.The initial sample was also retested on the original analyzer which obtained a lower result.The lower results were considered correct and a corrected report was issued to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2025-00168 was initially filed on 15-sep-2025.Correction: in the initial report, under section h11, the assay name was inadvertently documented as "atellica im total hcg (thcg)" in the following statement: ¿a customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.¿ the correct assay name is "advia centaur total hcg (thcg)".
Additional Manufacturer Narrative
Mdr 1219913-2025-00168 was initially filed on 15-sep-2025.Additional information (24-sep-2025): siemens received further details regarding the sample identifiers and third-party service information.Section b6 was updated to include the sample identifiers for the affected patient samples.Section d8 was updated to ¿no.¿.

• Brand Name: ADVIA CENTAUR THCG
• Common Device Name: ADVIA CENTAUR 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: 23049146
• Report Number: 1219913-2025-00168
• Device Sequence Number: 15888206
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: (01)00630414505176(10)90851363(17)251124
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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: 11/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 90851363
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: Not provided; 09/24/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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: 21 YR
• Patient Sex: Female