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	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely depressed enzymatic creatinine_3 (ecre3) and total bilirubin_2 (tbil_2) patient results were obtained on an atellica ch 930 analyzer (s/n: (b)(6) v1.30.1).The erroneous results were reported to the physician(s).The samples were repeated on alternate instruments.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report falsely depressed enzymatic creatinine_3 (ecre3) and total bilirubin_2 (tbil_2), patient results were obtained on an atellica ch 930 analyzer (s/n: cm01119, v1.30.1).No error messages were seen on the user interface (ui).The washers were checked, it was observed that one of the dilution washer probes had a lot of crystallization and dirt.The next day, the customer service engineer (cse) was on site and checked the system message logs and found errors for the dilution arm.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced the dilution probe and dilution washer probe 1, which were clogged.The cse replaced the sample probe.The cse also checked the dilution washer lines and dilution cuvettes.Siemens further investigated the event and identified that the possible potential cause of the event was due to sample related variables or a dirty dilution probe.The customer is operational, and the complaint was resolved by routine troubleshooting.No further investigation 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 ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 24910119
• Report Number: 2432235-2026-00094
• Device Sequence Number: 13044437
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 03/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2019
• 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