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	08/15/2025
Type of Reportable Event	Malfunction
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 thcg lot 362.A discordant elevated thcg result was observed among a series of tests for one patient.The sample was tested multiple times, on two instruments, due to a history of issues with their on-site atellica im system.For this sample, results from the atellica im instrument were consistent, but results from testing on the atellica ci 1900 instrument were not; one falsely-elevated result was identified.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 elevated atellica im total hcg (thcg) results which were discordant relative to repeat testing.The appearance of the affected samples indicates no visible fibrin.No issues were identified with quality control (qc) or other sample results.Siemens is investigating.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated atellica im total hcg (thcg) results which were discordant relative to repeat testing.Mdr 1219913-2025-00165 was initially submitted on 11-sep-2025.Update, 01-oct-2025: siemens has concluded the investigation.Two samples were tested multiple times on two instruments, and each sample produced one falsely-elevated result on the atellica ci instrument.Quality control (qc) results were within established ranges on the days of testing.No signs of fibrin were noted when the samples were visually inspected.Instrument autocheck data indicate no malfunctions.A review of internal reagent release data showed that the assay lot met all applicable specifications.Return of the patient samples for further investigation is not warranted as the discordant results were not reproducible.Review of instrument logs showed no issues affecting sample or reagent aspiration or dispense actions.Following review of the data, the local service team proactively replaced the sample probe chain and z-axis assembly on 05-sep-2025.Following service, thcg precision was verified by running replicates of qc samples.A specific cause for the discordant results could not be identified.The observations appear to be sample-specific; other patient samples tested using the same reagents did not demonstrate similar imprecision.The customer is operational, and there is no evidence of a systemic reagent or instrument problem.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 ; 5082985306
• MDR Report Key: 23025599
• Report Number: 1219913-2025-00165
• Device Sequence Number: 9428264
• Product Code: DHA
• UDI-Device Identifier: 00630414600031
• UDI-Public: (01)00630414600031(10)60173362(17)250906
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K192790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 10/01/2025

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 Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 60173362
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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