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

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	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant elevated calcium_2 (ca_2) results obtained on multiple patient samples on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens that discordant elevated calcium_2 (ca_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The initial results were reported to the physician(s), and the results were questioned.The samples were not reprocessed.The customer did not provide the information regarding the specific sample identifiers questioned by the physician(s).No treatment was provided or delayed based on the elevated results.There was no delay in reporting results.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated ca_2 results.
Additional Manufacturer Narrative
Additional information (10-feb-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Quality control (qc) recovered higher when processed using specific calibration but within the customer¿s expected ranges, indicating that the calcium_2 (ca_2) assay was performing acceptably.Siemens determined that there was no issue with performance of the atellica ch 930 analyzer.The cause of the event is unknown.Siemens conducted an internal investigation in response to the reported event of elevated ca_2 results obtained when calibrated using a specific calibrator for calibration.The internal testing for all chem cal lots tested showed that the ca_2 performance was within the manufacturer's claims.However, to support customers in optimizing patient recoveries when using specific chem cal lot, siemens provided an optional calibrator value assignment, which is only applicable to that calibrator lot.A customer letter is available to support this suggested change.No product problem was identified.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.Initial mdr 2432235-2024-00365 was filed on 29-dec-2024.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CALCIUM_2 (CA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; crumlin, co. antrim; registration # 8020890 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: 21032168
• Report Number: 2432235-2024-00365
• Device Sequence Number: 19835610
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: (01)00630414220697(10)242276(17)250601
• Combination Product (Y/N): N
• 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): 03/05/2025

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: 06/01/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097644
• Device Lot Number: 242276
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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