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	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneously depressed calcium (ca) results were obtained on three (3) patient samples on the atellica ch 930 analyzer.Calibration and quality control (qc) were acceptable on the day of the event.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneously depressed calcium (ca) results were obtained on three (3) patient samples on the atellica ch 930 analyzer.The initial results were reported to the physician(s) but not questioned.The same samples were repeated on an alternate atellica ch 930 analyzer.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ca results.
Additional Manufacturer Narrative
Siemens filed initial on 11-mar-2026.Additional information (08-apr-2026): siemens healthcare diagnostics has concluded the investigation of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse reviewed the instrument error logs and observed multiple occurrences of reagent 1 (r1) probe errors.The cse performed alignments on the r1 probe and made slight adjustments.The cse also auto-aligned the reagent 2 (r2) probe with no issue observed.The cse verified instrument performance post-service by running ca precision studies using quality control (qc) material, and all results were acceptable.Siemens further evaluated the event and determined that the instrument malfunction potentially contributed to the falsely depressed ca results.The instrument is performing according to specifications.No further evaluation is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated to reflect the additional information.

• 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 MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24566851
• Report Number: 2432235-2026-00073
• Device Sequence Number: 15827627
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 04/28/2026

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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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