MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; ATELLICA IM TOTAL HCG (THCG) 90T

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	01/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported an observation of an elevated atellica im total human chorionic gonadotropin (thcg) patient result for a sample, which was discordant relative to repeat testing.Calibration was acceptable, and quality control (qc) was within the laboratory established ranges when the discordant result was obtained on the day of the event.The customer ran qc the next day, which recovered out of range.The customer changed the reagent pack, recalibrated the assay, and ran qc, which recovered acceptably.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." siemens is evaluating the event.
Event or Problem Description
The customer reported an observation of an elevated atellica im total human chorionic gonadotropin (thcg, lot # 365) patient result for a sample, which was discordant relative to repeat testing.The initial elevated result was reported to the physician(s), who did not question the result.The sample was retested on the original atellica im 1300 analyzer.The retested result was lower than the initial result and was in line with the customers¿ expectations.A corrected report was issued by reporting the retested result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2026-00042 was initially filed on 19-feb-2026.Additional information (02-mar-2026): siemens concluded the investigation of a united states (us) customer complaint regarding an observation of an elevated atellica im total human chorionic gonadotropin (thcg) patient result for a sample, which was discordant relative to repeat testing.Siemens evaluated the instrument data, and the information provided by the customer.Siemens¿ review of the instrument data for the discordant sample showed no evidence of a hardware issue.The customer ran the thcg master curve material (mcm), and all levels were within range with acceptable precision.Also, quality control (qc) recovered within range following calibration.Siemens performed internal testing across multiple thcg reagent and calibrator lots, and all calibrator lots were within specification and met the acceptance criteria.Siemens determined that there was no reagent or instrument related issue.Based on the available information, the cause of the single discordant result was unable to be determined.A product problem was not identified.The customer is operational.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) 90T
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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: 24385781
• Report Number: 1219913-2026-00042
• Device Sequence Number: 10208336
• Product Code: DHA
• UDI-Device Identifier: 00630414600031
• UDI-Public: (01)00630414600031(10)58099365(17)260425
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 03/23/2026

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: 10995690
• Device Lot Number: 58099365
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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 Sex: Unknown