MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; ATELLICA IM TOTAL HCG (THCG) 450T

Catalog Number	10995689
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated total human chorionic gonadotropin (thcg) result obtained on a patient sample on an atellica im 1300 analyzer.Siemens reviewed the instrument data files and the information provided by the customer and found that the auto check results were within the acceptable range.Quality control (qc) recovered acceptably on the day of the event, and no issues were reported with other patient samples and ruled out the total human chorionic gonadotropin (thcg) reagent problem.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit the cse inspected the analyzer nd performed a complete service and found no problems related to the analyzer.There is no indication of a systemic reagent or analyzer related cause.Based on the available information, siemens determined that the cause of the erroneously elevated thcg result is unknown.The customer is operational.The device is performing according to the specification.No further evaluation is required.
Event or Problem Description
The customer reported that they obtained an erroneously elevated total human chorionic gonadotropin (thcg) result on a patient sample on an atellica im 1300 analyzer.The erroneous result was reported to the physician and was questioned.The sample was repeated twice on the same analyzer, and the repeat results were lower than the initial result.The repeat results were consistent with patient¿s clinical history, considered correct.A corrected report was issued with the result as <5 iu/l.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated thcg result.

• Brand Name: ATELLICA IM
• Common Device Name: ATELLICA IM TOTAL HCG (THCG) 450T
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1219913; 333 coney st.; 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: 24914334
• Report Number: 1219913-2026-00080
• Device Sequence Number: 13060422
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)96919366(17)260718
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/17/2026

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: 07/18/2026
• Device Catalogue Number: 10995689
• Device Lot Number: 96919366
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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: 31 YR
• Patient Sex: Female