MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH CALCIUM (CA)

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed calcium (ca) result on one (1) patient sample obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens one (1) erroneously depressed calcium (ca) patient sample result obtained on an atellica ch 930 analyzer.The erroneously depressed patient result was not reported to the physician.The same sample was reprocessed on an alternate atellica ch 930 analyzer.A higher result was obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed result with calcium (ca).
Additional Manufacturer Narrative
Additional information (23-july-2025): siemens healthcare diagnostics service operations support (sos) team concluded the investigation of the event.A customer service engineer (cse) performed multiple service actions on the atellica ch 930 analyzer.No other discordant results were reported after these service actions.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6, has been updated to reflect the sos investigation.Initial mdr 2432235-2025-00170 was filed 25-june-2025.

• Brand Name: ATELLICA CH CALCIUM (CA)
• 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: linda barletta ; 500 gbc drive; newark, DE 19714-6101
• MDR Report Key: 22326815
• Report Number: 2432235-2025-00170
• Device Sequence Number: 8411431
• Product Code: CIC
• UDI-Device Identifier: 00630414595672
• UDI-Public: (01)00630414595672(10)242413(17)260301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K991576
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 03/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097595
• Device Lot Number: 242413
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2024
• 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 Age: 81 YR
• Patient Sex: Male