MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; 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	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneously depressed sodium (na) result on a patient sample was obtained on the dimension exl 200 integrated chemistry system.The customer stated that quality control (qc) level 1 and level 3 results and calibration were within acceptable lab range prior to running patient samples.Siemens investigation included an assessment of reagent, instrument, and sample data.Reagent related causes were ruled out based on the review of qc and also observed that air and liquid values of standard (std) a and std b were within the normal range.The customer recalibrated the integrated multisensor technology (imt) successfully.Qc were run and were recovered within acceptable range.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit the cse, inspected the analyzer and replaced the x2 tubing, ran conditioning, and adjusted the pump rate.Based on the available information, there is no evidence of a reagent or instrument scenarios.The cause of the event is unknown.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.No further evaluation is required.
Event or Problem Description
The customer reported that an erroneously depressed sodium (na) result was obtained for a patient sample on the dimension exl 200 integrated chemistry system.The erroneous result was reported to the physician(s) and was questioned.The sample was repeated on the same dimension exl 200 integrated chemistry system.The repeat result was higher than the initial result and was considered correct.The patient was sent to the emergency room (er) due to the depressed result.A new sample was drawn again in the er and tested; the result obtained was similar to the previous repeat result.Both repeat results were consistent and considered correct.The redrawn sample result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: DIMENSION
• 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: 25252674
• Report Number: 2517506-2026-00086
• Device Sequence Number: 14826708
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/22/2026

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
• Initial Report FDA Received Date: 05/22/2026
• 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