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

Catalog Number	DF207 SMN 10700795
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed tacrolimus (tac) results obtained on thirteen (13) patient samples on a dimension exl 200 integrated chemistry system.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained erroneously depressed tacrolimus (tac) results on thirteen (13) patient samples on a dimension exl 200 integrated chemistry system.The erroneous results were reported to the physician and were questioned.The same samples were sent to an alternate facility and reprocessed on an alternate non-siemens instrument.The reprocessed results were considered correct and reported to the physician.The customer did not provide the patient results obtained from an alternate non-siemens instrument.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed tacrolimus (tac) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2025-00050 on 26-mar-2025.Additional information (11-nov-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens evaluated the instrument data, and the information provided by the customer.Calibration was acceptable, and quality control (qc) was within the customer's acceptable ranges.Siemens reviewed the instrument data and found that the system check was acceptable, and the tacrolimus (tac) reagent lot demonstrated reduced reactivity.Siemens could not perform additional studies as the tac reagent lot was near expiry.The customer performed a comparison study, and the results were not considered acceptable.Siemens reviewed the tac reagent release records for the affected lot and found no anomalies.Based on the available information, the cause of the discordant results cannot be determined and is inconclusive due to data limitations.The customer is operational.The instrument is performing according to specifications.No further evaluation is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated to reflect the additional information.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TACROLIMUS 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21695772
• Report Number: 2517506-2025-00050
• Device Sequence Number: 9281771
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: (01)00842768035425(10)GA5091(17)250401
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150168
• 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): 12/05/2025

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: 04/01/2025
• Device Catalogue Number: DF207 SMN 10700795
• Device Lot Number: GA5091
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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 Sex: Unknown