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

Model Number	AELLICA CH 930
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an atellica ch 930 analyzer.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse found that the triple probe for reaction washer 3 was broken at the bend for the water probe.The cse replaced the triple probe, performed alignment on the angular path of the dilution arm and level sense reliability testing which passes, performed full auto check which passes.Further the cse performed automated empty and fill of bath.The customer ran calibration and quality control (qc) which recovered acceptably.Siemens further evaluated the event and determined that the wash station droplets and the broken wash probe potentially contributed to the falsely elevated co2_c result.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a falsely elevated concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an atellica ch 930 analyzer.The initial result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate atellica ch 930 analyzer.The repeat result recovered lower than the initial result and was considered correct.The repeat result was reported as a correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c result.

• Brand Name: AELLICA CH 930
• Common Device Name: AELLICA CH 930
• 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: 24492624
• Report Number: 2432235-2026-00066
• Device Sequence Number: 4979644
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/03/2026

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: AELLICA CH 930
• 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: 02/09/2026
• Initial Report FDA Received Date: 03/02/2026
• 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