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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a discordant result was obtained for a glucose (gluc) result on one patient sample on a dimension exl 200 analyzer.Siemens remotely reviewed the instrument data.Siemens advised the customer to replace and realign the reagent probe 1 (r1) probe tip and clean the r1 drain.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced a leaking reagent probe 2 (r2) drain and aligned r2.The cse cleaned the windows and checked other drains for leaks.The cse found a small leak from a sealed reagent tray opening for reagent management system (rms) attachment.The cse cleaned, reseated, and resealed the cover.No more leaks were seen.The cse primed pumps and ran a system check.The customer ran quality controls (qc) which recovered acceptable results.Based on on-site findings, the most likely cause of the event was fluidic leakage around the r2 drain and reagent tray seal.The combination of a leaking r2 drain and a secondary leak at the reagent tray rms opening created inconsistent reaction conditions until both were repaired and resealed.The instrument is operational, and the complaint was resolved with routine troubleshooting.
Event or Problem Description
The customer reported a discordant result was obtained for a glucose (gluc) result on 1 patient sample on a dimension exl 200 analyzer.The result was flagged with an abnormal reaction and was not reported to the physician(s).The sample was repeated on the same instrument.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the abnormal reaction errors.

• 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; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 24349635
• Report Number: 2517506-2026-00041
• Device Sequence Number: 4759404
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: (01)00630414593579
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/16/2026

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: 01/23/2026
• Initial Report FDA Received Date: 02/16/2026
• 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