MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM TOTAL HCG (THCG)

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	06/18/2025
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) result which was discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.The sample and reagent trace files were reviewed which showed no evidence of aspiration and/or dispense issues affecting thcg reagent delivery and autocheck data were within specifications.Return of the patient sample for further investigation by siemens was not warranted because the discordant result was not reproducible.A proactive service was dispatched to the customer's site.The siemens customer service engineer (cse) inspected the aspirate probes and determined that the analyzer was performing acceptably.Based on the available information, the cause of the discordant result was unable to be determined.A product problem has not been identified, and the issue was resolved by routine troubleshooting.The customer is operational, and no further actions are required.
Event or Problem Description
The customer reported observation of an elevated atellica im total hcg (thcg) result which was discordant relative to repeat testing when using lot# 362.An initial elevated thcg result was obtained for the patient in question.The elevated result was reported to the physician(s), but it is unknown if the result was questioned by the physician(s).A new sample was drawn from the same patient and tested on the original analyzer which produced a lower result.For troubleshooting purposes, both samples were retested on an alternate analyzer (atellica ci 1900), which produced lower results similar to the result obtained from the second sample.The lower result was considered correct, and a corrected report was issued to the physician(s) based on repeat testing.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Common Device Name: ATELLICA IM TOTAL HCG (THCG)
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22554131
• Report Number: 1219913-2025-00147
• Device Sequence Number: 9785278
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)60171362(17)250906
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: 09/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 60171362
• 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: 06/26/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: Female