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	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an erroneously depressed sodium (na) result was obtained on a dimension exl 200 integrated chemistry system.The sample was repeated on the original system.Additionally, a new sample was drawn from the same patient and processed on the original system.The redrawn sample result was higher than the initial result, considered correct, and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium 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 dimension exl 200 integrated chemistry system.The customer replaced standard a (std a) with same lot, ran successful calibration and quality control (qc) which recovered low, replaced integrated multisensor technology (imt) sensor, ran dilution check, corrected the bias.The customer observed that the original sample was clear, adequately filled, ran in a primary tube, and the analyzer pump rate was elevated.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse adjusted imt pump rate, replaced rotary valve, performed successful system checks and imt calibration, super flossed ports for the rotary valve and imt tower, observed high pump rate and adjusted it.The customer ran qc and 10 patient samples, which recovered within acceptable range.Siemens further evaluated the event and determined that the cause of the event cannot be determined.The device is performing according to specifications.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.; 62 flanders bartley rd; registration #: 2247117; 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: 50728740
• Report Number: 2517506-2026-00138
• Device Sequence Number: 10586764
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/11/2026

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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• 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 Age: 74 YR
• Patient Sex: Male