MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM

Model Number	DIMENSION EXL WITH LM 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	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report falsely depressed sodium (na) results were obtained on 2 patient samples on a dimension exl with lm integrated chemistry system.Siemens reviewed the na quality controls (qc) data and observed that level 1 and level 2 results were within acceptable range.The calibration passed prior to running the patient samples.Review of the solid-state material (ssm) data found that air and liquid values of std a and std b were within the normal range.The calibration was acceptable with lytes slope in range.The dilution check passed with bottle values and standard deviation (sd) of na within normal range on the day of the event.The customer bleached the integrated multisensor technology (imt) and replaced the imt tubing.Qc were run.The qc recovered within acceptable range.No further occurrences of the behavior were reported by the customer.Based on the available information, the probable cause of the event is related to the flow through the imt, specifically with the imt tubing.The customer is operational, and the complaint was resolved with routine maintenance actions.No further investigation is required.
Event or Problem Description
The customer reported falsely depressed sodium (na) results were obtained on 2 patient samples on a dimension exl with lm integrated chemistry system.The erroneous results were not reported to the physician(s).The samples were repeated on an alternate instrument.The repeat results were higher than the erroneous results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Common Device Name: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; newark DE
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 24845226
• Report Number: 2517506-2026-00067
• Device Sequence Number: 8926926
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: (01)00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SELFDECLARED
• 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): 04/10/2026

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 WITH LM INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: 10472176
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/10/2026
• 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: Unknown