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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated cardiac troponin i (ctni) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.The initial result was not reported to the physician(s).The sample was repeated twice on the same dimension exl 200 integrated chemistry system.The repeat results obtained were lower than the initial result and were considered correct.The repeat result of 0.0073 ng/ml was reported as correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated ctni result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) regarding a falsely elevated cardiac troponin i (ctni) result obtained on a patient sample on a dimension exl 200 integrated chemistry system.Siemens reviewed the luminescent oxygen channeling immunoassay (loci) module data and no malfunctions were identified.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the system and examined the sampler, reagent 2 (r2) tubing, syringes, and ultrasonics in diagnostics, and found no issues.Then, the cse replaced the sample probe, r2 probe & tubing, ultrasonic head, and syringe seals, followed by cleaning the r2 wash station, vessel bin, and heterogeneous module (hm) incubation ring and performed decontamination.Next, the cse checked the sample and reagent probe cleaner, confirming it was properly loaded and not expired.Further, the cse verified all related parts and system performance, and the customer ran quality control (qc), which recovered acceptably.Siemens further evaluated the event and determined that the malfunctioned sampler, r2 probes and tubing potentially contributed to the falsely elevated ctni result.The instrument was performing within 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.; 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: 22060246
• Report Number: 2517506-2025-00080
• Device Sequence Number: 18260034
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: (01)00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/21/2025

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: 05/11/2025
• Initial Report FDA Received Date: 05/21/2025
• 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