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
Siemens investigated a united states customer report of an elevated atellica im total hcg (thcg) patient result that was considered discordant versus repeat testing on an alternate atellica im analyzer.Siemens customer service evaluated customer data including, reagent calibration and quality control (qc), and reviewed the analyzer log files.Only this specific sample was considered discordant, as a preventive measure, siemens customer service engineer (cse) was dispatched to perform sample probe troubleshooting that included alignments and adjustments.Upon completion of the troubleshooting, precision and qc testing were performed.All qc replicates recovered within published insert ranges and precision was within expectation for the assay.The thcg assay is performing acceptably following standard service actions.Based on this information, the cause of the initial falsely elevated thcg patient result is inconclusive and isolated to a single sample.The instrument is operational and the thcg assay is performing acceptably following standard service actions.
Event or Problem Description
The customer obtained an elevated atellica im total hcg (thcg), lot 360, patient serum sample result that was reported and questioned by the physician because it did not match clinical picture of the patient.The sample was retested on a different atellica im analyzer in duplicate, and the results were lower as expected.A corrected report was issued.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.

• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 21282990
• Report Number: 1219913-2025-00030
• Device Sequence Number: 7830385
• Product Code: DHA
• UDI-Device Identifier: 00630414293776
• UDI-Public: (01)00630414293776(10)79056360(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
• Report Date (Section B): 01/31/2025

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: 11206261
• Device Lot Number: 79056360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/31/2025
• 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 Sex: Unknown