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	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial mdr 2517506-2025-00026 was filed with the fda on 21-feb-2025.Additional information (25-feb-2025): siemens reviewed the information provided and services performed by the customer service engineer (cse) and confirmed that the dimension exl 200 analyzer has performed as specified post-service repair.The customer has not observed a recurrence.The potential cause of the sodium and potassium falsely depressed results is a faulty sample probe.The analyzer is operational, and no further evaluation is required.
Event or Problem Description
The customer reported that sodium and potassium testing performed on the dimension exl 200 analyzer produced falsely depressed results on two patients (sample ids (b)(6)).The results were not reported to the physician(s).The customer performed repeat testing for sample id (b)(6) and noted that the results remained low; therefore, they performed gasometer testing and stated that the results were higher, within normal limits, considered correct, and reported the results to the physician(s).The customer performed repeat testing for sample id (b)(6) on the dimension exl 200 analyzer and noted that the results remained low.The customer performed troubleshooting, verified quality control (qc) results were acceptable, performed repeat testing on the sample id (b)(6), and stated the results were higher compared to the initial results, considered correct, and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The customer reported that sodium and potassium testing performed on the dimension exl 200 analyzer produced falsely depressed results on two patients (sample ids (b)(6)).The customer stated that quality control (qc) was verified at 9:10 p.M.And everything was correct.The customer performed troubleshooting and noted that the integrated multisensor (imt) qc results were within range after sensor lot replacement and also before and after observing the discordant sample results.Siemens dispatched a customer service engineer (cse) to the customer site.The cse changed the cap of the imt tower, imt x tubing and noted a dilcheck failure: sodium (na) ranged from 110 to 125.The cse changed the sample needle and consumables (std a, stb, salt bridge) and noted that the dilcheck diagnostic and qc were acceptable.The system was functional and required the recalibration of assays.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: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 21433502
• Report Number: 2517506-2025-00026
• Device Sequence Number: 17278397
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: (01)00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/28/2025

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: 02/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 02/28/2025
• 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