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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discordant sodium (na) and potassium (k) results were obtained on multiple patient samples on dimension exl with lm integrated chemistry system.The erroneous results were reported to the physician(s).The samples were repeated on an alternate instrument.The repeat results were reported, as the correct results, to the physician(s).The customer did not provide patient data.There are no known reports of patient intervention or adverse health consequences due to the discordant, sodium (na) and potassium (k) results.
Additional Manufacturer Narrative
An outside of the united states customer contacted a siemens customer care center to report that discordant sodium (na) and potassium (k) results were obtained on multiple patient samples on a dimension exl with lm integrated chemistry system instrument.Siemens remotely reviewed the instrument data and found that lytes quality control (qc) were within the acceptable range.The integrated multisensor technology (imt) calibration was not successful.This mdr is being filed in an abundance of caution as the customer did not provide patient data.A siemens customer service engineer (cse) was dispatched to the customer site and flossed the tower, port, and rotary valve, performed conditioning of the port and replaced the imt pump, tubing's rotary valve.Siemens further evaluated the event and concluded that the probable cause of the issue is consistent with fluid flow issues in the imt system.The instrument is fully operational.No further evaluation of this device is required.

• 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; po box 6101; newark DE 19714 6101
• 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: 22700702
• Report Number: 2517506-2025-00123
• Device Sequence Number: 18378815
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: (01)00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K130276
• 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): 08/04/2025

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: 07/11/2025
• Initial Report FDA Received Date: 08/04/2025
• 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