MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. 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	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated calcium_2 (ca_2) results on two (2) patient samples obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens they obtained erroneously elevated calcium_2 (ca_2) results on two (2) patient samples on an atellica ch 930 analyzer.The erroneously elevated results were not reported to the physician(s).The same samples were reprocessed on the original atellica ch 930 analyzer.Lower results were obtained, considered correct, and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated calcium_2 (ca_2) results.
Additional Manufacturer Narrative
Additional information (13-nov-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos evaluated the information provided by the customer and the available instrument data.Quality control (qc) was within the customer¿s acceptable ranges.The cause of the event is unknown.The customer stated the issue was resolved and no other discordant results were reported.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the sos investigation.Initial mdr 2432235-2025-00276 was filed on 15-oct-2025.

• Brand Name: ATELLICA CH CALCIUM_2 (CA_2)
• Common Device Name: CALCIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): RANDOX LABORATORIES LTD; 55 diamond road; registration # 8020890; crumlin, county antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: isaac dashefsky ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 9173315804
• MDR Report Key: 23304362
• Report Number: 2432235-2025-00276
• Device Sequence Number: 18648851
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: (01)00630414220697(10)252513(17)260501
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 05/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097644
• Device Lot Number: 252513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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