MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGE

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	02/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that an erroneously depressed cyclosporine a (csa) result was obtained on a patient sample on a dimension rxl max hm integrated chemistry system.The erroneously depressed result was not reported to the physician(s).The same sample was reprocessed twice on the original dimension rxl max hm integrated chemistry system.Higher reprocessed results were obtained and considered correct.The higher reprocessed result of 116.3 ng/ml was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed cyclosporine a (csa) result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed cyclosporine a (csa) result obtained on a patient sample on a dimension rxl max hm integrated chemistry system.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the instrument data files and the information provided by the customer.The review of the quality control (qc) data indicated that the initial qc was out of range and then recovered within range after qc aliquot change on the event date.The customer calibrated the csa assay, which recovered acceptably.The system check was good and within the acceptable limits.There were no dimension rxl max hm integrated chemistry system errors observed, and the issue was resolved by reprocessing the same sample on the original system.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21466684
• Report Number: 2517506-2025-00031
• Device Sequence Number: 14300644
• Product Code: MKW
• UDI-Device Identifier: 00842768025136
• UDI-Public: (01)00842768025136(10)BB5269(17)250926
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K023065
• 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
• Report Date (Section B): 02/26/2025

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: 09/26/2025
• Device Model Number: N/A
• Device Catalogue Number: DF89A SMN 10285193
• Device Lot Number: BB5269
• 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: 02/03/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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: 24 YR
• Patient Sex: Female