MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH CALCIUM_2 (CA_2)

Catalog Number	SMN 11097644
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported that the initial elevated calcium_2 (ca_2) results obtained on multiple patient samples on an atellica ch 930 analyzer were questioned by the physician(s) when reported.Siemens is evaluating the event.
Event or Problem Description
The customer reported that the initial elevated calcium_2 (ca_2) results obtained on multiple patient samples on an atellica ch 930 analyzer were questioned by the physician(s) when reported.The samples were reprocessed on an alternate atellica ch 930 analyzer.No corrected reports were issued.The customer did not provide the patient sample data.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00233 on 11-sep-2025.Additional information (17-sep-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer, and the available instrument data files.Quality control (qc) recovered outside the customer's acceptable ranges when ran with a specific lot calibration, and the qc recovered within the customer's acceptable ranges when ran with other calibrations.Siemens reviewed the calibration data and found that the affected lot calibration showed a significantly lower calibration coefficient and average signal responses than other calibrations performed using the same reagent and calibrator lots, which indicated that any samples processed using the affected lot calibration show elevated calcium_2 (ca_2) results.Siemens evaluated the event and determined that the anomaly with the specific lot calibration potentially contributed to the reported event.The cause of the anomaly with the lot calibration is unknown.The customer resolved the event by recalibrating.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CALCIUM_2 (CA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23024669
• Report Number: 2432235-2025-00233
• Device Sequence Number: 9819793
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: (01)00630414220697(10)242373(17)251001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083386
• 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): 10/08/2025

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 Expiration Date: 10/01/2025
• Device Catalogue Number: SMN 11097644
• Device Lot Number: 242373
• 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: 08/17/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown