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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer reported that a falsely high test result for total bilirubin (tbil_2) was produced on an atellica ch 930 analyzer.The operator replaced the reagent probe (rp2) and the dilution probe.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse ran an autocheck with acceptable results.The cse performed mechanical alignments.A level sense reliability check determined the transfer arm was warped causing the probe to be at an angle.The warping led to intermittent level sense errors.The cause of the falsely high total bilirubin test result was an intermittent level sense error due to a warped transfer arm.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 that a falsely high test result for total bilirubin (tbil_2) was produced on an atellica ch 930 analyzer.The initial test result was released to a physician.The same sample was repeated on an alternate atellica ch 930 analyzer.The test result data from the alternate analyzer was considered correct and released to a physician.There are no known reports of patient intervention or adverse health consequences due to the event.

• 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: 24802397
• Report Number: 2432235-2026-00089
• Device Sequence Number: 21502562
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/07/2026

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: 03/29/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown