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	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed sodium (na) result on a patient sample on an atellica ch 930 analyzer.Calibration was acceptable, and quality control (qc) recovered within range on the event date.The customer recalibrated the integrated multisensor technology (imt), and repeated qc, which recovered within range.Siemens further evaluated the event and concluded that the cause of the erroneous na result is consistent with a sample integrity behavior, most likely, fibrin in the sample was aspirated on the initial aspiration causing a decreased sample volume to be aspirated thus causing the lower na recovery.The initial aspiration cleared the fibrin from the sample and repeat aspirations were not affected.The reported issue was resolved with standard troubleshooting actions.The customer is operational.The device is performing according to specifications.No further evaluation of this device is required.
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 reported to the physician(s), who did not question the result.A new sample was redrawn from the same patient and processed on the original atellica ch 930 analyzer.The redrawn result obtained was considered correct.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the reported event.

• 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: 22477673
• Report Number: 2432235-2025-00182
• Device Sequence Number: 8498833
• Product Code: JGS
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)150001(17)260120
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/11/2025

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: 01/20/2026
• Device Model Number: N/A
• Device Catalogue Number: 11099315
• Device Lot Number: 150001
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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