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	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained erroneously depressed carbon dioxide, concentrated (co2_c) results on three patient samples on an atellica ch 930 analyzer.The erroneous results were reported to the physician(s) and were questioned.The samples were repeated on an alternate atellica ch 930 analyzer.The repeat results recovered higher than the initial result, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed co2_c results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed carbon dioxide, concentrated (co2_c) results obtained on three patient samples on an atellica ch 930 analyzer.Calibration was acceptable.Quality control (qc) results were acceptable before the event and out of range after the event.Siemens reviewed the instrument data files and the information provided by the customer and noticed that the issue started after maintenance was performed on the distilled water system.Siemens also found a pattern in the milli-absorbance units (maus) indicating a water-quality issue.The co2_c assay is sensitive to water quality, especially resistivity; when resistivity is low, the calibration mau values begin to decrease.A new calibration after fresh water is flushed through the system should restore the co2_c calibrator maus to typical levels, and qc will be acceptable and stable.After the maintenance, the customer performed a pack calibration instead of lot calibration, and the qc results were unacceptable.The customer then performed lot calibration, after which the co2_c calibrator maus returned to typical levels and the qc results were acceptable.Based on the available information, siemens determined that the maintenance performed on the distilled water system potentially contributed to the erroneously depressed co2_c results.The analyzer is performing according to specifications.No further evaluation is required.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 2247117; 62 flanders bartley rd; 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: 24616831
• Report Number: 2432235-2026-00077
• Device Sequence Number: 18538273
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 03/17/2026

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: 02/19/2026
• Initial Report FDA Received Date: 03/17/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown