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	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) and reported that a falsely depressed calcium (ca) result was obtained on a patient sample on an atellica ch 930 analyzer.Quality control (qc) and calibration results were within acceptable limits prior to running the patient samples.The customer ran qc and precision.Siemens remotely assisted the customer and verified that shifts in patient results were not associated with a change in reagent pack id or well or calibration id.A full system autocheck was run and identified a failure for probe thermal fluid heater current, which was out of range.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse ran service methods and autocheck, replaced the reagent mixer, sample mixer impeller, dilution mixer impeller, and dilution probe, and aligned all mixers, dilution probe, and sample probe.The cse then primed the system and ran qc, which recovered acceptably.Further the cse, performed total service visit, ran service methods, replaced mixer and aligned, and identified that the probe 3 of reaction washer was dripping periodically into the reaction ring, replaced both valves to probe 3, leak resolved and repeated mix methods for sample mixer, ran auto check, qc and all other service methods, which recovered acceptably.Siemens is evaluating the issue.
Event or Problem Description
The customer reported that a falsely depressed calcium (ca) result was obtained on a patient sample on an atellica ch 930 analyzer.The initial result was reported to the physician(s), who did not question the result.The sample was repeated on an alternate atellica ch 930 analyzer.The repeat result correlated with patient history/clinical status and was 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 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2026-00107 on 15-may-2026.Additional information (21-may-2026): siemens reviewed the customer's quality control (qc) data, which showed slight imprecision and, in some instances, recovery outside of expected ranges.A review of the ca results in question showed that the low discrepant results occurred intermittently.Multiple other ca results were processed using the same ca reagent pack/well and calibration event (calibration id), with no recovery issues.The data also showed that qc was processed after the results in question, using the same reagent pack/well and calibration id, and recovery was within expected ranges.Siemens evaluated the event and concluded that the instrument related causes potentially contributed to the falsely depressed ca result.The investigation conclusions code in section h6 was updated to reflect additional information.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: 25180744
• Report Number: 2432235-2026-00107
• Device Sequence Number: 10653086
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/22/2026

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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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