MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CI; ATELLICA CI 1900 ANALYZER

Model Number	ATELLICA CI 1900 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an erroneously elevated total hcg (thcg) patient sample result was obtained when processed on an atellica ci 1900 analyzer (s/n: (b)(6).An initial elevated result was obtained for the patient sample in question.The elevated result was reported to the physician who questioned the result.The same sample was then reprocessed on an alternate atellica ci 1900 analyzer, which produced a lower result.The lower result was considered correct as it was consistent with the clinical picture of the patient, and a corrected report was issued to the physician.There are no known reports of patient intervention or adverse health consequences due to the elevated thcg result.
Additional Manufacturer Narrative
A united states (us) customer contacted siemens and reported that an erroneously elevated total hcg (thcg) patient sample result was obtained when processed on an atellica ci 1900 analyzer.Siemens evaluated the instrument data, the information provided by the customer, and the instrument performance, which included the siemens customer service engineer (cse) total service visit.A visual inspection of the sample tube showed no evidence of bubbles, foam, or fibrin.Thcg calibration was valid, and quality control results were within range both before and after testing the specimen.No issues were identified with other patient samples.The sample was not returned for internal investigation because the reported elevated result was non-reproducible.During the service visit, the cse inspected the analyzer and replaced the acrylic wash block assembly, including tubing and fittings, tightened o-rings, and replaced valves.Following the routine troubleshooting intervention, the reported issue was resolved.Based on the available information, the cause of the discordant elevated result was unable to be determined.The instrument is performing according to specifications, and no further evaluation is required.

• Brand Name: ATELLICA CI
• Common Device Name: ATELLICA CI 1900 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25374168
• Report Number: 2432235-2026-00121
• Device Sequence Number: 9462959
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K222116
• 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): 06/03/2026

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 Model Number: ATELLICA CI 1900 ANALYZER
• Device Catalogue Number: 10947347
• Device Lot Number: N/A
• 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: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• 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: A
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female