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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of united states (ous) customer reported observation of an erroneously depressed total human chorionic gonadotropin (thcg) result which was discordant relative to repeat testing.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that a depressed atellica im total human chorionic gonadotropin (thcg) result was obtained which was discordant relative to repeat testing when using lot# 365.An erroneously depressed result of 895.7miu/ml was initially reported to the physician and was questioned.The patient was redrawn, the sample was diluted (1:5), and retested on the same atellica im 1600 analyzer, yielding a result of 2331.1miu/ml.The patient was drawn again, and the new sample processed on the same analyzer produced a result of 2435.6 miu/ml.The elevated results were considered correct.There are no known reports of patient intervention and adverse health consequences due to the erroneously elevated total human chorionic gonadotropin (thcg) result.
Additional Manufacturer Narrative
Mdr 1219913-2026-00052 was initially filed on 09-mar-2026.Additional information (15-apr-2026): siemens healthcare diagnostics has concluded the investigation of the event.An outside of united states (ous) customer reported observation of an erroneously depressed total human chorionic gonadotropin (thcg) result which was discordant relative to repeat testing.Siemens evaluated the instrument data, and the information provided by the customer.Reagent and instrument issues were ruled out based on qc recovery within acceptable ranges and no issues were reported with other patient samples.Sample integrity was confirmed through visual inspection of the collection tube.The sample and reagent trace files were reviewed which showed no evidence of hardware issues affecting thcg reagent delivery.No issues were observed with other diluted samples processed with same diluent pack.Based on the available information, the cause of the discordant result cannot be determined.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• 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: 24543659
• Report Number: 1219913-2026-00052
• Device Sequence Number: 21150170
• Product Code: DHA
• UDI-Device Identifier: 00630414600024
• UDI-Public: (01)00630414600024(10)58098365(17)260425
• 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): 05/10/2026

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: 04/25/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 58098365
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 29 YR
• Patient Sex: Female