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	06/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated atellica im total hcg (thcg) result for a male cancer patient which was discordant relative to repeat testing when using thcg lot 363.An initial elevated atellica im thcg result was obtained for a male patient undergoing treatment for testicular cancer.This initial result was questioned by the physician and the test was repeated twice; both repeat tests produced much lower results (<2.0 miu/ml).The lower results were accepted as correct, as they were consistent with patient history.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 duplicate repeat testing.Siemens is investigating.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) result for a male cancer patient which was discordant relative to repeat testing.Mdr 1219913-2025-00113 was initially submitted on 12-jun-2025.Update, 02-jul-2025: siemens has concluded the investigation.For the affected patient, an initial thcg result was falsely elevated relative to two follow-up measurements.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Issues with reagent function can be effectively ruled out as quality control (qc) results were within expected ranges and no issues were reported for any other patient samples.Review of instrument files showed no evidence of any hardware issues affecting the delivery of assay reagents for the discordant test.There was an anomalous pressure profile identified for the dispense of the affected sample.The observed profile is within specification but may indicate a potential preanalytical (sample quality) issue.Based on the available information, the probable cause of the discordant result is a sample quality issue.No systemic product problem was identified.The customer is operational, and the reported issue was resolved by repeating the testing of the sample.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.; 511 benedict ave; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5085335363
• MDR Report Key: 22193417
• Report Number: 1219913-2025-00113
• Device Sequence Number: 8628308
• Product Code: DHA
• UDI-Device Identifier: 00630414600031
• UDI-Public: (01)00630414600031(10)90854363(17)251124
• 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): 07/02/2025

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: 10995690
• Device Lot Number: 90854363
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/02/2025
• 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 Sex: Male