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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated sodium (na) result was obtained for a patient on a dimension exl 200 integrated chemistry system.The erroneous result was reported to the physician(s).The physician questioned the result.The result was repeated on the same instrument.The repeat result was lower than the erroneous result.The repeat result was reported as the correct result to the physician(s).
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a falsely elevated sodium (na) result was obtained for a patient on a dimension exl 200 analyzer.Quality controls (qcs) recovered out of ranges on the day of the event.The qc failure was related to the integrated multisensor technology (imt) diluent in port.It was found that the imt diluent was completely empty.The diluent bottle was replaced.The sample was repeated.The repeat result was within normal range.Siemens is investigating 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: 25257106
• Report Number: 2517506-2026-00088
• Device Sequence Number: 10541497
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/15/2026

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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2021
• 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