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	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an erroneously depressed sodium (na) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.The initial discordant result was not reported to the physician.The sample was repeated on the original instrument.The repeat result recovered higher than the initial result, and was considered correct as, it matched the patient's historical profile.The repeat result was 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
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) regarding a erroneously depressed sodium (na) result obtained on a patient sample on a dimension exl 200 integrated chemistry system.The quality control (qc) was recovered within range on the date of the event.A siemens customer service engineer (cse) was dispatched to the customer site.During the visit, the cse replaced all tubing including port drain tubing, performed repeatability test and comparison of 10 sample.The cause of the erroneously depressed na result is unknown.Siemens is evaluating the event.
Additional Manufacturer Narrative
Initial mdr report 2517506-2025-00110 submitted on 16-jul-2025.Additional information received on 15-oct-2025: siemens reviewed instrument data, observed air and liquid values of standard (std) a and standard (std) b were within the normal range, calibration was acceptable with lytes slope in range and precision tests were within specifications on the days of incident.Siemens further reviewed analyzer data files, observed the dilution check factor was high and not within range and fluctuations in air flow.In addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse), during second visit replaced all integrated multisensor technology (imt) tubings (x, x0, x1, x2, x3), imt port, tightened sample probe, aligned sample probe in imt port, styletted imt fittings on tower and port, ran dilution check which passed, noted correction factor to be within range, ran precision test for quality control (qc) and patient samples which recovered within specification.Siemens further evaluated the event and determined that the flow issue through imt potentially contributed to the falsely depressed sodium (na) results.The system is operational and performing within specification.No further evaluation/troubleshooting is required investigation conclusion code in the h6 section was updated to reflect the additional information.

• 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.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22518450
• Report Number: 2517506-2025-00112
• Device Sequence Number: 15441724
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: (01)00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 10636928
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 11/10/2025
• 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