MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)

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	04/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed potassium (k) result was obtained on a patient sample on an atellica ci 1900 analyzer.The erroneous result was not reported to the physician(s).The same sample was reprocessed on the original analyzer and twice on an alternate atellica ci 1900 analyzer.The reprocessed results matched the clinical history and were considered correct.The reprocessed result from an alternate analyzer was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely depressed k result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed potassium (k) result obtained on a patient sample on an atellica ci 1900 analyzer.Calibration was acceptable, and quality control (qc) was within the range on the day of the event.Siemens reviewed the information provided by the customer, and the available instrument data files.Siemens' review of the instrument data indicated that lot release data met all specifications for release and was not different from other sensor lots.Siemens¿ review of the instrument data indicated that the patient sample showed a difference with all electrolytes that were consistent with the presence of fibrin or particulates in the sample causing the differences in results.A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25111289
• Report Number: 2432235-2026-00103
• Device Sequence Number: 9321860
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)150014(17)261013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222438
• 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): 05/07/2026

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: N/A
• Device Catalogue Number: 11099315
• Device Lot Number: 150014
• 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: 04/18/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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