MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that a falsely low sodium test result was obtained for one patient sample from a dimension exl 200 analyzer.A siemens operational support (sos) specialist connected remotely to the customer site.Sos found the imt pup rate was 82.1 and stable.Tubing x0 and x1 were clean.The sample probe count was 19,000 cycles.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse found that the sample ultrasound block was in contact with the arm¿s metal support and that the ultrasound r1 probe was also in contact with the metal support.The cse replaced the 2 motors on the sample syringe panel, replaced the 2 sample syringes and replaced the sample tubing.The cse adjusted the 2 home positions of the syringe panel, removed the imt port and performed reaming and bleach cleaning.The cse aligned the sample probe with the imt port, replaced all imt tubing and performed maintenance on the rotary valve.The cse replaced the peristaltic tubing and aligned it to a flow rate set to 81 l/revolution), replaced the kcl, diluent, quick lyte reagents and primed the fluid lines.Internal quality control materials (iqc) were run with acceptable results.The cause of the falsely low sodium test result is unknown.Improper alignments at the ultrasound block were a contributing factor.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
A falsely low sodium test result was obtained for one patient sample from a dimension exl 200 analyzer.The initial test result was not released to a physician.The same sample was repeated on the same and an alternate dimension exl 200 analyzer.The test result from the alternate analyzer was higher, considered correct and released to a physician.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 24755352
• Report Number: 2517506-2026-00060
• Device Sequence Number: 8779676
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/01/2026

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: 10636929
• Device Lot Number: N/A
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male