MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Inc. Dimension EXL 200 Integrated Chemistry System

Model Number	Dimension EXL 200 Integrated Chemistry System
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained an erroneously depressed sodium (na) result on a patient sample on a dimension exl 200 integrated chemistry system.The initial result was not reported to the physician(s).The sample was repeated on the same dimension exl 200 integrated chemistry system and higher result was obtained.The repeat result was reported to the physician(s) as correct result.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed na result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed sodium (na) result obtained on a patient sample on a dimension exl 200 integrated chemistry system.Quality control (qc) recovered acceptably.Siemens reviewed the instrument data files and the information provided by the customer and found that the calibration recovered at the lower end of the acceptable range.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit the cse inspected the system and found dried fluid deposits and contamination around the integrated multisensor technology (imt) detector, x1 tubing connections, salt bridge ports and evidence of fluid leakage within the imt assembly.Then, the cse replaced the imt pump assembly, roller head, rotary valve tubing, imt tower/detector assembly, and sensor.Next, the cse performed sensor conditioning, dilution check, and qc verification, reset the dilution correction factor, conditioned and dilcheck and applied new correction, new sensor was installed, performed qc which recovered acceptably.Based on the available information, the probable cause of the erroneously depressed na result is consistent with degraded imt fluid-path and leakage around the detector and fluid pathway components.A product issue was not identified.The instrument was performing according to the specification.No further evaluation is required.

• Brand Name: Dimension EXL 200 Integrated Chemistry System
• Common Device Name: Dimension EXL 200 Integrated Chemistry System
• Manufacturer (Section D): Siemens Healthcare Diagnostics Inc.; 500 gbc drive; po box 6101; newark DE 19714 -610
• Manufacturer (Section G): Siemens Healthcare Diagnostics Inc.; registration #: 2247117; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50895615
• Report Number: 2517506-2026-00144
• Device Sequence Number: 18817943
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K130276
• 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): 09/25/2026

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 EXL 200 Integrated Chemistry System
• Device Catalogue Number: 10636929
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male