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	11/27/2025
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) results which was discordant relative to repeat testing.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 thcg lot 364.The customer tested the sample of a 17-year-old female patient both neat and diluted 200-fold.The result for the diluted sample was elevated, while the undiluted result was below assay measuring range.The elevated result was reported, and later identified as falsely elevated.When the same sample was repeat tested on the same instrument, the neat (undiluted) result was the same (below range), and the dilution produced an overdilution error (overdiluted; below linearity).A second sample was tested twice on a different atellica im analyzer, and it reproduced the low results seen in the re-test of the first sample.When both samples were sent to an external laboratory for testing, results from a roche cobas system were non-detectable for hcg.Additionally, an ovarian ultrasound was performed showing no ovarian pathology.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.No issues were identified with quality control (qc) or any other sample results.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) results which was discordant relative to repeat testing.Update, 15-jan-2026: siemens has concluded the investigation.A result following sample dilution was identified as falsely elevated, and was not reproduced in repeat testing.Results from an alternate method confirmed the low results obtained in repeat atellica im testing.No issues were identified with quality control (qc) or any other sample results.The sample that produced the discordant result was visually inspected and there were no signs of fibrin, debris, or clots.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Review of reagent probe log files showed no evidence of any issues affecting delivery of thcg reagents.Review of the sample probe trace files identified a need for service to proactively inspect the sample probe for a slight leak and to check probe alignments.Additionally, instrument data from the date of the discordant result were within acceptable limits, but wash station vacuum was relatively high with an increasing trend.Service was requested to perform prescribed vacuum troubleshooting steps.After recommended service interventions, the thcg assay was calibrated and tested.Qc was within range and dilution replicates produced acceptable results.A specific cause for the isolated falsely elevated thcg could not be determined.The customer remains operational, and no systemic product problem was identified.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: 23704621
• Report Number: 1219913-2025-00215
• Device Sequence Number: 10641308
• Product Code: DHA
• UDI-Device Identifier: 00630414600031
• UDI-Public: (01)00630414600031(10)24478364(17)260209
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 01/15/2026

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: 02/09/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 24478364
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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: 17 YR
• Patient Sex: Female