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

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that the erroneous carbon dioxide, concentrated (co2_c) and creatinine_2 (crea_2) results were obtained on multiple patient samples on the atellica ch 930 analyzer.Siemens has evaluated the photometric data and observed that a sudden decrease in mau (milli-absorbance unit) between cycles when no instrument activity (sample addition, reagent addition, mixing) was taken.The discrepant results were consistent with droplets from a reaction wash probe falling into a cuvette during test processing.A siemens customer service engineer (cse) was dispatched to the customer site.During the visit, the cse inspected the analyzer, observed droplets at the reaction wash probe 1 dispense point, and replaced the associated valve (v19).Siemens further evaluated the event and concluded that the wash station droplets and the malfunctioned valve 22 potentially contributed to the event.The instrument is performing according to specifications.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneous carbon dioxide, concentrated (co2_c) and creatinine_2 (crea_2) results were obtained on multiple patient samples on the atellica ch 930 analyzer.The erroneous results were reported to the physician(s) but not questioned.The samples were repeated on alternate atellica ch 930 analyzers.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous co2_c and crea_2 results.

• 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 ; +919(870)577433
• MDR Report Key: 24516761
• Report Number: 2432235-2026-00068
• Device Sequence Number: 9723625
• Product Code: JJE
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/15/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 09/15/2026
• 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