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	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that falsely depressed ammonia (amm) results were obtained on two patient samples on the atellica ch 930 analyzer.The initial results were not reported to the physician.The same samples were repeated on alternate atellica ch 930 analyzer.The repeat results obtained were higher than the initial results and considered correct.The repeat results were reported as correct results to the physician.There are no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) regarding falsely depressed ammonia (amm) results on two patient samples were obtained on the atellica ch 930 analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the analyzer and performed a full auto check, which passed successfully.The cse, then performed automatic and manual alignments on the dilution arm and all mixers.Additionally, the cse removed and replaced the sample mixer paddle, after which the sample mixing performance was found to be within specifications.Furthermore, the cse aligned all mixers and recalibrated the lamp.Siemens is evaluating the event.

• 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 Manufacturing Limited; registration number: 8020888; chapel lane, swords, co.; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50686109
• Report Number: 2432235-2026-00217
• Device Sequence Number: 16058177
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 09/09/2026

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: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• 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