MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION TACROLIMUS FLEX; ENZYME IMMUNOASSAY, TRACROLIMUS

Model Number	DIMENSION TACROLIMUS FLEX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information (12-may-2026): siemens healthcare diagnostics headquarters service operations support (sos) team concluded the investigation of the event.Sos reviewed the instrument data files and the information provided by the customer.Quality control (qc) recovery was within the customer¿s expected ranges.The issue was resolved with standard troubleshooting by repeating the sample with and without dilution.No reagent nor instrument issues were identified.A potential product issue was not identified.The cause of the event was consistent with a sample specific issue.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens an erroneously elevated tacrolimus (tac) result was obtained on one (1) patient sample on a dimension exl 200 integrated chemistry system.The erroneously elevated result was not reported to the physician.The same sample was reprocessed on the same dimension exl 200 integrated chemistry system three additional times: once using a 1:2 dilution, using no dilution, and using another 1:2 dilution.Lower results were obtained.The result obtained using the second 1:2 dilution was 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 TACROLIMUS FLEX
• Common Device Name: ENZYME IMMUNOASSAY, TRACROLIMUS
• 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: christopher aebig ; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 9144153450
• MDR Report Key: 25323499
• Report Number: 2517506-2026-00089
• Device Sequence Number: 10128517
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: (01)00842768035425(10)GA6316(17)20261112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/28/2026

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: DIMENSION TACROLIMUS FLEX
• 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: 05/06/2026
• Initial Report FDA Received Date: 05/28/2026
• 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 Sex: Unknown