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	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed potassium (k) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on the original instrument for troubleshooting purposes.Then the same sample was repeated on non-siemens instrument.The repeat result from non-siemens instrument recovered higher than the initial result and was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely depressed k result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) and reported that a falsely depressed potassium (k) result was obtained on a patient sample on the dimension exl 200 integrated chemistry system.Quality control (qc) and calibration results were within acceptable limits prior to running the patient sample.The customer replaced sensor and ran dilution check.Siemens remotely assisted the customer and performed 3 integrated multisensor technology (imt) soaks, primed all reagents for 5 times and ran quality control (qc) and repeated sample.Siemens reviewed the available instrument data files and the review of the instrument data indicated that air and liquid values of std a and std b, calibration, pump rate and dilution check were within the acceptable range.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse identified crimped xo tubing and snipped that primed air bubbles out of xo tubing, replaced x tubing, ran passing calibration, qc, and dilution check, which recovered acceptably.Siemens evaluated the event and determined that the crimped x0 tubing and issue with x tubing potentially contributed to the falsely depressed potassium (k) result.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25078915
• Report Number: 2517506-2026-00080
• Device Sequence Number: 21433269
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/05/2026

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: 04/10/2026
• Initial Report FDA Received Date: 05/05/2026
• 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