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	03/01/2025
Type of Reportable Event	Malfunction
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.Assay calibration and quality control (qc) results were consistent and within expected ranges for both reagent packs.The same assay calibration was applied in the repeat testing.Siemens is investigating.
Event or Problem Description
The customer reports observation of elevated atellica im total hcg (thcg) results which were discordant relative to repeat testing when using lot: thcg 361.Discordance was identified for five (5) patients in repeat testing using atellica im thcg.Elevated thcg results were observed for several patients; these results were reproducible in duplicate testing.One of these results was questioned by a physician, as testing using another platform had produced a ¿negative¿ result for that patient.As a result, thcg testing was repeated for all samples which had been tested on that day.Repeat testing performed the following day using a fresh sample aliquot and a new reagent pack produced much lower results (within or below the reference range for non-pregnant females), which were considered consistent with clinical expectation.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.Mdr 1219913-2025-00051 was initially submitted on 12-mar-2025.Update, 28-mar-2025: siemens has concluded the investigation.Several samples were affected, and initial elevated results were reproducible when testing was repeated within a short period of time.It was determined that the discordant initial tests were all performed from the same reagent pack.When the affected samples were re-tested the following day, lower (correct) results were generated.Quality control (qc) results for thcg were acceptable both before and after the discordant tests.It was noted, however, that qc failures affected several other assays during this time period.It was further identified that the directions of the observed shifts in qc results corresponded with differences in essential assay architecture, suggesting a systemic affect on all assay applications.Analysis of signal-generation data showed that this instrument was generating higher-level signals during a 5-hour period.Review of fluidics data did not identify any systemic issues affecting aspiration or dispense of samples or reagents.However, secondary vacuum pressure and pump speed demonstrated variations on the morning of the discordant results.Vacuum performance was normal afterward.A specific cause for the discordant results could not be identified, but no systemic product problems were identified.The observed issue appears to be an isolated event, where the customer continued to run the instrument and report results without repeating assay qc.The customer is operational, the reported issue was resolved by routine troubleshooting.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: 21583688
• Report Number: 1219913-2025-00051
• Device Sequence Number: 8896313
• Product Code: DHA
• UDI-Device Identifier: 00630414600031
• UDI-Public: (01)00630414600031(10)19601361(17)250526
• 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): 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): 03/28/2025

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: 19601361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/28/2025
• 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