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	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that an erroneously depressed sodium (na) result was obtained on a patient sample on an atellica ch 930 analyzer.Calibration and quality control (qc) were acceptable on the day of the event.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they observed an erroneously depressed sodium (na) result obtained on a patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on two different alternate atellica ch 930 analyzers.The repeat results from the alternate atellica ch 930 analyzers were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00315 on 12-dec-2025.Additional information (16-dec-2025): siemens reviewed the information provided by the customer, and the available instrument data files.Siemens' review of the instrument data indicated presence of bubbles in sample.There is no reported issue with quality control recovery and no reported behavior with other patient samples.Siemens evaluated the event and determined that the cause of the behavior is due to sample quality consistent with presence of bubbles and/or fibrin.A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.

• 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: 23786968
• Report Number: 2432235-2025-00315
• Device Sequence Number: 13375172
• Product Code: JGS
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)150005(17)260421
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 04/21/2026
• Device Model Number: N/A
• Device Catalogue Number: 11099315
• Device Lot Number: 150005
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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: 80 YR
• Patient Sex: Male