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	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us)customer contacted a siemens customer care center to report a falsely depressed sodium (na) result was obtained on a patient sample on a dimension exl 200.Quality controls (qcs) recovered out of ranges on the day of the event.The customer replaced the x tubing and integrated multisensor technology (imt) sensor.As per siemens instructions, the customer cleaned the gold pogo pins, flushed the reagent probe 1 (r1) tubing, replaced the salt bridge, and adjusted the x tubing and imt pump rate.The customer then performed the requested maintenance and replaced the sensor.Siemens walked the customer through backwashing the imt port.The salt, std a, std b were primed and flushed.The waste flow was verified.The qcs were run; all recovered within range.Siemens further reviewed and established that the probable cause of the event is tied to the formation of debris, crystals, or micro clots in the imt, affecting the flow through the imt.The instrument is operational.No further evaluation of this device is required.
Event or Problem Description
The customer reported a falsely depressed sodium (na) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.The erroneous result was not reported to the physician(s).The sample was repeated on the same instrument.The repeat result was higher than the erroneous result.The repeat result was 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 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 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 25184842
• Report Number: 2517506-2026-00083
• Device Sequence Number: 10755240
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/15/2026

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: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2022
• 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