MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed sodium (na) result was obtained on a patient sample on an atellica ch 930 analyzer.The initial result was not reported to the physician(s).The sample was repeated on an initial analyzer.The repeat result recovered higher than the initial result and was correlate with result on alternate atellica ch 930 analyzer.The repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed na result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed sodium (na) result was obtained on a patient sample on an atellica ch 930 analyzer.The customer performed advanced clean and installed a new sensor.Siemens remote service center (rsc) remotely assisted the customer and installed a new peristaltic pump tubing, primed fluids and recalibrated integrated multisensor technology (imt).A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse manually adjusted imt forward so the dilution probe wasn't hitting the side of the sample port, ran comparison study and quality control (qc) and all were acceptable.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2026-00053 on 18-feb-2026.Additional information (19-feb-2026): in addition to the service activities mentioned in the initial report, the customer service engineer (cse) performed system verification with quality control (qc) and correlation.Siemens further evaluated the event and concluded that the sample quality which may have had bubbles, fibrin or clot contributed to the falsely depressed sodium (na) result.The instrument is performing according to specifications.No further evaluation of this device is required.The component code, investigation findings and investigation conclusions codes have been updated in h6 section to reflect the additional information.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24374849
• Report Number: 2432235-2026-00053
• Device Sequence Number: 5583318
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151767
• 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): 03/04/2026

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 CH 930 ANALYZER
• Device Catalogue Number: 11067000
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown