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	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported that erroneously depressed results were obtained on multiple patient samples for carbon dioxide, concentrated (co2_c), enzymatic creatinine_3 (ecre3) and total bilirubin_2 (tbil_2) on an atellica ch 930 analyzer.The customer noted that the wash probe was spraying into all the reaction cuvettes and found that washer probe 1 was continuously dispensing water.The customer removed all the reagents from the system and turned off the power.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, observed that the reaction washer probe 1 water valve was stuck open.The cse replaced the washer probe 1 water valve, performed auto check, observed washer probe 5 waste valve was clogged, replaced probe 5 waste valve, reloaded reagents and restarted system, this sequence of events caused the reagent inventory to become confused, unloaded and reloaded reagents, restarted computers, shut down and rebooted the entire line.Siemens reviewed the instrument data, and the photometer data indicated sudden decrease in milli-absorbance unit (mau).Siemens further evaluated the event and determined that the wash station droplets and the failed valve potentially contributed to the discordant (co2_c), (ecre3) and (tbil_2) results.The instrument performing according to the specification.
Event or Problem Description
The customer reported that the erroneously depressed carbon dioxide, concentrated (co2_c), enzymatic creatinine_3 (ecre3) and total bilirubin_2 (tbil_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.For the co2_c the initial results were reported to the physician(s).For ecre3 and tbil_2 the customer didn't provide the initial results.Therefore, the initial results were reported to the physician is unknown.The same samples were repeated on the alternate atellica ch 930 analyzer¿s.The repeat results correlated with the patient¿s clinical status and were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2026-00105 on 11-may-2026.Additional information (16-may-2026): at the time of filing the initial mdr, the customer had not provided siemens with any patient result information for the enzymatic creatinine_3 (ecre3) and total bilirubin_2 (tbil_2) assays.Therefore, the initial mdr was filed conservatively for the ecre3 and tbil_2 assays.However, the customer has now provided additional information and confirmed that no discordant results were obtained for the ecre3 and tbil_2 assays.Accordingly, the assessment previously made for the ecre3 and tbil_2 assays should be disregarded.

• 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: 25133983
• Report Number: 2432235-2026-00105
• Device Sequence Number: 21211430
• 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,Followup
• Report Date (Section B): 06/10/2026

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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/16/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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