MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM

Model Number	DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that while performing troubleshooting on a leak that was coming from the dimension exl with lm integrated chemistry system, the customer accidentally ripped the positive cable off the reagent probe cleaner pump.The customer received an electric shock when touching the cable, which was hanging loose.The leak was in one of the wash solution pump cassettes behind the syringe panel.Per siemens instructions, the customer replaced a wash solution pump cassette to stop the leak.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the cse visit, it was observed that a solenoid valve connector cable located between the reagent probe 1 (r1) syringes was completely oxidized and severed.The cse resoldered the cable.Based on the information provided, the probable cause of the leak is due to the wash solution pump cassette.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that while performing troubleshooting for a leak that was coming from the dimension exl with lm integrated chemistry system, the customer accidentally ripped the positive cable off the reagent probe cleaner pump.The customer received an electric shock when touching the cable, which was hanging loose.

• Brand Name: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Common Device Name: DIMENSION EXL WITH LM 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: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 24661156
• Report Number: 2517506-2026-00055
• Device Sequence Number: 12022373
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: (01)00842768030024
• Combination Product (Y/N): N
• 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): 03/23/2026

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 WITH LM INTEGRATED CHEMISTRY SYSTEM
• Device Catalogue Number: 10472176
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2015
• 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 Age: 37 YR
• Patient Sex: Female