MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Inc. Dimension; Dimension Tacrolimus Flex reagent cartridge

Model Number	N/A
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneous tacrolimus (tac) results were obtained on two patient samples on a dimension exl 200 integrated chemistry system.The initial results were reported to the physician(s) and questioned.The samples were repeated on the original system.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous tac results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneous tacrolimus (tac) results obtained on two patient samples on a dimension exl 200 integrated chemistry system.Siemens is evaluating the event.

• 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 -610
• Manufacturer (Section G): Siemens Healthcare Diagnostics Inc.; 500 gbc drive; po box 6101; newark DE 19714 -610
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50931827
• Report Number: 2517506-2026-00148
• Device Sequence Number: 18518848
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• 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): 09/29/2026

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: GA7007
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2026
• 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