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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) regarding an erroneously elevated tacrolimus (tac) result on a patient sample obtained on a dimension exl 200 integrated chemistry system.Quality control (qc) and calibration recovered within the acceptable ranges on the date of the event.Siemens evaluated the patient¿s reproducibility data, aspiration pressure profiles, clot-check information, and photometric reaction data, which demonstrated pressure variation during the initial aspiration event, while repeat analyses showed stable aspiration patterns and consistent reaction performance.Siemens did not identify any evidence of system malfunction, reagent performance issue, calibration instability, or assay-related failure.Siemens further evaluated the event and determined that the sample-related aspiration disturbance (kind of fibrin/micro-clot) contributed to the erroneously elevated tac result.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported that they obtained an erroneously elevated tacrolimus (tac) result on a patient sample on a dimension exl 200 integrated chemistry system.The initial result was not reported to the physician.The sample was repeated twice on the original dimension exl 200 integrated chemistry system.The repeat results recovered lower than the initial result and matched the patient¿s clinical history.The repeat results were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tacrolimus (tac) result.

• 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: 25467731
• Report Number: 2517506-2026-00096
• Device Sequence Number: 9933355
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: (01)00842768035425(10)GA7056(17)270225
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 10700795
• Device Lot Number: GA7056
• 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: 05/18/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2026
• 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