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	03/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) and reported that the erroneous carbon dioxide, concentrated (co2_c) and creatinine_2 (crea_2) results were obtained on the multiple patient samples on an atellica ch 930 analyzer.Quality control (qc) was acceptable prior to the erroneous results.Siemens remotely assisted the customer and reviewed the system message logs, and the pressure transducer in reagent arm 1 detected that aspiration of reagent did not occur, ran full system auto check, removed and inspected dilution probe and reagent probe 1 (rp1), replaced dilution probe, customer cleaned probe and reseated, powered off rp1 and reagent probe 2 (rp2), removed reagent server cover, initialized rp1/rp2, auto aligned reagent server 1, reagent probe 1, dilution probe, primed all probes for 10 times, replaced rp1 and repeated auto check, and resumed ch module, which recovered acceptably.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse identified a leak in the tubing for the sample probe, replaced the coupler for sample prober water, primed all probes, ran auto check, checked wash probe 3 for reaction washer, ran extended leak test, and restarted the analyzer, all of which recovered acceptably.The cause of the event is unknown.
Event or Problem Description
The customer reported that the erroneous carbon dioxide, concentrated (co2_c) and creatinine_2 (crea_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The erroneous results were not reported to the physician(s).The 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 the erroneous co2_c and crea_2 results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2026-00090 on 08-apr-2026.Additional information (18-apr-2026): in addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse) ran autocheck, which indicated an error related to reaction washer probe 1; replaced reagent probe 1 (rp1), reaction washer probe 1, and the sample probe tubing; performed automatic alignments on reagent arm 1, reagent arm 2, and dilution arm; and reran autocheck.The cse also checked for dripping from the dilution and reaction washers and performed an extended probe leak test.No drips were observed.Siemens reviewed the information provided by the customer and the available instrument data files.Siemens' review of the instrument data indicated the results were elevated and exhibited a sudden decrease in mau during the reaction at a time when no instrument actions were taking place.This was consistent with intermittent droplets from the reaction wash station.Siemens evaluated the event and determined that the bubbles/foaming after sample mix and intermittent droplets from the reaction wash station are the two potential contributors; however, the cause of the discrepant results could not be determined based on the available information.The service activities performed by the cse described in the initial report and this report, resolved the issue.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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: 24816620
• Report Number: 2432235-2026-00090
• Device Sequence Number: 5952259
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/05/2026

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: 03/15/2026
• Supplement Date Received by Manufacturer: 04/18/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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