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	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed microalbumin_2 (alb_2) result was obtained on a patient sample on an atellica ch 930 analyzer.The initial result was reported to the physician(s).The sample was reprocessed on the original analyzer.The repeat result matched the patient¿s clinical assessment.The repeat result was reported as correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely depressed alb_2 result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed microalbumin_2 (alb_2) result was obtained on a patient sample on an atellica ch 930 analyzer.Siemens reviewed instrument data and determined that calibration and quality control (qc) results were acceptable on the day of the event.Qc was run after the discordant results were obtained, which recovered low.Siemens further evaluated the event and determined that the cause of the event is unknown.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: 25595543
• Report Number: 2432235-2026-00147
• Device Sequence Number: 12107931
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/23/2026

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: 06/02/2026
• Initial Report FDA Received Date: 06/23/2026
• 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 Age: 68 YR
• Patient Sex: Female