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	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of reproducibly elevated atellica im total hcg (thcg) results for one patient which were discordant relative to repeat and alternate-method testing.Assay calibration and quality control (qc) results have been within acceptance ranges.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 and alternate-method testing when using lot thcg 360.A 40-year-old patient produced an elevated atellica im thcg result in advance of an iud (intrauterine device) insertion; the patient claimed not to be pregnant.The next day, the patient carried out a rapid immunofluorescence test using a capillary blood sample, and the result was negative.The original sample was re-tested twice for troubleshooting purposes, and the results were still elevated.The patient challenged the initial elevated thcg result, and a new sample was collected and measured using the same instrument.This sample produced a much lower result (below reference cutoff).Additional investigative testing was performed on this patient¿s samples.Both the first and second sample were re-tested using a dimension instrument, and a high result was obtained for the first sample, and low result for the second.The first sample, which had been reproducibly elevated, was also tested following hbt (heterophilic blocking tube) treatment.The results for this sample were consistently elevated in duplicate testing on both atellica im systems.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 and alternate-method testing.Mdr 1219913-2025-00028 was initially submitted on 24-jan-2025.Update, 14-mar-2025: siemens has concluded the investigation.Two samples from the same patient produced conflicting results, where results from the first sample were falsely elevated.Thcg calibration and quality control (qc) results were within expected ranges and no issues were reported for any other samples.Review of instrument data showed no evidence of any aspiration or dispense issues affecting the delivery of the sample or reagents.Based on the available information, a specific cause for the falsely elevated results observed for the first sample could not be identified.The issue was isolated to one particular sample from this patient.No systemic product problems were 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: 21229554
• Report Number: 1219913-2025-00028
• Device Sequence Number: 8292712
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)78070360(17)250222
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/14/2025

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: 10995689
• Device Lot Number: 78070360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/14/2025
• 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