MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH CYSTATIN C_2 (CYSC_2); TEST, CYSTATIN C

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	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained discordant cystatin c_2 (cysc_2) results on two (2) patient samples when processed on an atellica ch 930 analyzer.It is unknown which results are 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 cystatin c_2 (cysc_2) patient sample results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two (2) cystatin c_2 (cysc_2) discordant patient sample results were obtained when processed on an atellica ch 930 analyzer.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (26-sep-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 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 2432235-2025-00244 was filed on 18-sep-2025.

• Brand Name: ATELLICA CH CYSTATIN C_2 (CYSC_2)
• Common Device Name: TEST, CYSTATIN C
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• 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: 23088239
• Report Number: 2432235-2025-00244
• Device Sequence Number: 9711048
• Product Code: NDY
• UDI-Device Identifier: 00630414236919
• UDI-Public: (01)00630414236919(1)242366(17)260401
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181082
• 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): 10/13/2025

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: 11097647
• Device Lot Number: 242366
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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