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	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer reported observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.No issues were noted with respect to system errors or quality control (qc) results.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 360.An initial elevated result (above reference interval) was obtained for a female patient in her 40s.The patient took a home pregnancy test, which produced a negative result.Following this, additional testing was performed.Testing of both the original and new samples, using both the original reagent lot and using lot 362, produced much lower results which were accepted as correct.There are no allegations of any adverse patient effects, nor of any diagnostic delay, in association with the observed discordance.
Additional Manufacturer Narrative
A united states customer reported observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing.Mdr 1219913-2025-00018 was initially submitted on 14-jan-2025.Update, 27-feb-2025: siemens has concluded the investigation.No issues were noted with respect to system errors or quality control (qc) results.Review of instrument fluidics data showed no evidence of any aspiration or dispense anomalies affecting the samples in question, nor were there any indications of any hardware issues affecting delivery of thcg reagents.Service recommendations were made on the basis of the overall review and adjustments were made to the instrument, but no definitive cause was identified for the discordant observation.The reported issue was resolved following standard service actions.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 ; 5082985306
• MDR Report Key: 21149159
• Report Number: 1219913-2025-00018
• Device Sequence Number: 9189820
• Product Code: DHA
• UDI-Device Identifier: 00630414600031
• UDI-Public: (01)00630414600031(10)76510360(17)250222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 02/22/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 76510360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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 Age: 40 YR
• Patient Sex: Female