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	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer complained of low atellica im cyclosporine (csa) lot 055 patient results.A discordant result was identified where a patient sample tested on (b)(6) 2025 with atellica im csa resulted lower than a result 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 complained of low atellica im cyclosporine (csa) lot 055 patient results.A discordant result was identified where a patient sample tested on (b)(6) 2025 with atellica im csa resulted lower than a result 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.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a depressed atellica im cyclosporine (csa) result relative to alternate-method testing.Mdr 1219913-2026-00021 was initially submitted on 20-jan-2026.Update, 02-mar-2026: siemens has concluded the investigation.The customer complained of low quality control (qc) and patient-result bias when using csa lot 055, since november of 2025.Two events were identified where patient results were clinically discordant relative to alternate-method testing performed at another site.[refer to mdr 1219913-2026-00021 for the other reported event.] siemens sent on-site service, but did not find anything suspicious at the site to explain their issues.Review of qc performance over an extended period showed slight negative bias, but results within expected ranges with good precision.Closer examination showed that qc results in november and january were below target ranges.Additional information required to investigate this issue was requested but not provided.The customer has indicated that they have switched to testing csa using a different platform.Based on the available information, further evaluation is not possible.A specific cause for the observed discordance could not be determined, but no systemic product problem was identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• 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 10591
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24116830
• Report Number: 1219913-2026-00022
• Device Sequence Number: 9689357
• 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
• Serviced by Third Party (Y/N): Unknown
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• 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 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