MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that a falsely low creatinine (crea_2) test result was obtained for one patient sample from an atellica ch 930 analyzer.The customer reported that the "photometric lamp intensity out of range" error auto-corrected and that the analyzer is performing normally.A siemens regional support specialist (rsc) investigated the reported issue by reviewing log file data.Photometer data indicated that the lamp intensity went out of range and then resolved itself by coming back into range.This behavior indicates the photometer lamp needs to be replaced by the customer.As designed, for wavelengths that are out of range, the analytical module will stop producing results for assays that use those wavelengths.The wavelengths that were intermittently out of range were 410nm and 451nm and are not used for crea_2 testing.The cause of the falsely low crea_2 test result was a fluctuating lamp.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
An outside of the united states (ous) customer reported a falsely low creatinine (crea_2) test result was obtained for one patient sample from an atellica ch 930 analyzer.The initial result was released to a physician.The same sample was repeated on an alternate atellica ch 930 analyzer.The repeat result was higher and released to a physician as the correct result.The analyzer posted a "photometric lamp intensity out of range" error while the test was processing.There are no known reports of patient intervention or adverse health consequences due to the photometric lamp intensity out of range error.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 24489769
• Report Number: 2432235-2026-00065
• Device Sequence Number: 10676257
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/02/2026

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: N/A
• Device Catalogue Number: 11067000
• Device Lot Number: N/A
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown