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

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens three (3) calcium (ca) discordant patient sample results were obtained when processed on multiple atellica ch 930 analyzers.It is unknown which of the results is correct or if any of the results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant calcium (ca) patient sample results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding three (3) calcium (ca) discordant patient sample results were obtained when processed on multiple atellica ch 930 analyzers.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (30-sep-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.A customer service engineer (cse) performed routine service tasks (adjustments and part replacements) on the atellica ch 930 analyzer.The technical application specialist (tas) ran multiple precision studies using both quality control (qc) and patient samples.All qc precision showed acceptable results and no evidence of imprecision.Based on the available information, 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.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2025-00217 was filed on 20-aug-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: isaac dashefsky ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 22850375
• Report Number: 2432235-2025-00217
• Device Sequence Number: 4362410
• Product Code: CIC
• UDI-Device Identifier: 00630414595672
• UDI-Public: (01)00630414595672(10)252470(17)260401
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,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: 04/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097595
• Device Lot Number: 252470
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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