MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated tacrolimus (tac) patient result obtained on a dimension exl 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported that an erroneously elevated tacrolimus (tac) result was obtained on one patient sample on a dimension exl 200 integrated chemistry system.The initial result was not reported to the physician.The sample was reprocessed twice on the original instrument.The first repeat result recovered higher than the initial result and was considered erroneous.The second repeat result recovered similar to the initial result.The initial and the second repeat results were considered correct and the result of 10.4 ng/ml was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tac result.

• Brand Name: DIMENSION TACROLIMUS FLEX REAGENT CARTRIDGE
• 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: 24668041
• Report Number: 2517506-2026-00056
• Device Sequence Number: 5067518
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: (01)00842768035425(10)GA6316(17)261112
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: GA6316
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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 Age: 70 YR
• Patient Sex: Male