MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION SIROLIMUS 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	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens healthcare diagnostics remote services center (rsc) and reported that erroneously elevated sirolimus (siro) results were obtained on two patient samples on a dimension exl 200 integrated chemistry system.Quality control (qc) was within the range on the day of the event.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneously elevated sirolimus (siro) results were obtained on two patient samples on a dimension exl 200 integrated chemistry system.The erroneous results were reported to the physician(s), who questioned the results.The samples were reprocessed on the original system.The reprocessed results were lower than the erroneous results and were reported to the physician(s) as the correct results.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated sirolimus (siro) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2026-00001 on 02-jan-2026.Additional information (08-jan-2026): siemens concluded the investigation of the event.Siemens reviewed the instrument data files, and the information provided by the customer.Calibration was acceptable on the day of the event.The customer performed a precision study, which passed.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse performed a precision study across all three levels of quality control (qc), and the results were acceptable.There were no indications of any issues with reagent, sample pipetting, or delivery on the system.The cause of the event is unknown.A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION SIROLIMUS 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: 23941634
• Report Number: 2517506-2026-00001
• Device Sequence Number: 15411513
• Product Code: NRP
• UDI-Device Identifier: 00842768022111
• UDI-Public: (01)00842768022111(10)GB6275(17)261002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081857
• 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,Followup
• Report Date (Section B): 01/19/2026

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 Expiration Date: 10/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 10464331
• Device Lot Number: GB6275
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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