MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 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	01/20/2025
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.All quality control (qc) results for this assay were within expected ranges.No other issues were observed with this or any other assay, but it is noted that a similar observation was reported in december 2024.Siemens is investigating.
Event or Problem Description
The customer reports observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing when using lot thcg 361.An initial elevated atellica im thcg result was obtained for a 49-year-old male patient with testicular cancer.This result was questioned by the clinical pathologist, as the result was higher than expected.Within two hours, the same sample was repeat-tested twice on the same analyzer and twice as another atellica im instrument; the repeat results were consistently lower (<2 iu/l).The consensus lower results (four observations <2 iu/l) were accepted as correct.The initial elevated result was reported to the oncologist, but no action is believed to have been taken in response to the initial result.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
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.Mdr 1219913-2025-00027 was initially submitted to the fda on 23-jan-2025.Update, 21-feb-2025: siemens has concluded the investigation.Review of instrument data associated with the sample in question showed no evidence of a sample-integrity issue.Review of reagent fluidics data showed no indications of any hardware issues affecting delivery of thcg reagents.Other instrument checks showed acceptable performance.Service recommendations were made on the basis of the overall review, but no definitive cause was identified for the discordant observation.Based on the information available, a specific cause for the observed erroneous result could not be determined.However, no systemic product problem was identified.The customer is operational, and the thcg assay is performing acceptably; no further actions are required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5085335363
• MDR Report Key: 21218029
• Report Number: 1219913-2025-00027
• Device Sequence Number: 14332122
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)19602361(17)250526
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 10995689
• Device Lot Number: 19602361
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/21/2025
• 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