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	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained two erroneously depressed sodium (na) results on a patient sample on a dimension exl 200 integrated chemistry system.The initial result was reported to the physician(s) and was questioned.The sample was repeated on the same system and the result obtained was higher than the initial result but was in the critical range.The repeat result was reported to the physician(s) and was questioned.The physician(s) asked to redraw the sample.A new sample was drawn from the same patient and processed on the same system.The result obtained was higher than the previous results, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed na results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two erroneously depressed sodium (na) results obtained on a patient sample on a dimension exl 200 integrated chemistry system.Quality control (qc) recovered acceptably before the event.The customer noticed error with the integrated multisensor technology (imt) not calibrating, and replaced the sensor, performed condition and dil-check.The customer repeated the qc which recovered acceptably and ran precision study which was acceptable.A siemen¿s customer service engineer (cse) was dispatched to the customer¿s site.During the visit the cse inspected the system and replaced the x tubing, performed a super condition and pump alignment, adjusted the pump rate and calibrated the imt.Then, the cse performed qc and found a slight deviation.Further the cse performed precision study which was acceptable.Next the cse checked the imt waste valve function, imt port, sample metering syringe gap and the imt diluent gap and found no issues.Later the cse reran qc, which was acceptable, performed system check which passed.Based on the available information, the probable cause of the erroneously depressed na results is consistent with flow through imt with the formation of micro clot/ debris/ salt buildups.The instrument is working according to the specification.No further evaluation 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 -610
• Manufacturer (Section G): Siemens Healthcare Diagnostics Inc.; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50928237
• Report Number: 2517506-2026-00147
• Device Sequence Number: 9734271
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/29/2026

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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• 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