MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA IM CYCLOSPORINE (CSA)

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	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer reported discordant (low) atellica im cyclosporine (csa) lot 055 patient results.The customer provided data for 2 patient samples tested on (b)(6) 2026 where the initial atellica im csa were lower than results from an alternate method obtained at a different lab.There are no reports of patient or user intervention or adverse health consequences in association with this event.Siemens is investigating.
Event or Problem Description
The customer reported discordant (low) atellica im cyclosporine (csa) lot 055 patient results.The customer provided data for 2 patient samples tested on (b)(6) 2026 where the initial atellica im csa were lower than results from an alternate method obtained at a different lab.There are no reports of patient or user intervention or adverse health consequences in association with this event.

• Brand Name: ATELLICA IM CYCLOSPORINE (CSA)
• Common Device Name: CYCLOSPORINE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24114920
• Report Number: 1219913-2026-00021
• Device Sequence Number: 12258892
• Product Code: MKW
• UDI-Device Identifier: 00630414598727
• UDI-Public: (01)00630414598727(10)91691055(17)270122
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K071455
• Number of Events Summarized: 1
• Summary Report (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): 05/20/2026

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 Model Number: N/A
• Device Catalogue Number: 10995548
• Device Lot Number: 91691055
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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