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

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While emptying a cuvette waste bin on the dimension exl with lm instrument, a medical laboratory technologist observed a loop of used cuvettes hanging over the side of the cuvette waste bin.The technologist indicated when she flipped the loop of cuvettes into the bin, a few drops of liquid waste allegedly splashed onto her face.Subsequently, she felt a stinging sensation in one eye.The technologist rinsed her eye with eye wash and underwent a post-exposure protocol as per the laboratory's standard operating procedure (sop).No further medical attention was required.She was wearing corrective prescription lenses at the time of the incident.There are no known reports of adverse patient health consequences due to the event.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and have not been verified.
Additional Manufacturer Narrative
When a customer service engineer (cse) visited an outside of the united states (ous) customer for an unrelated issue, the customer reported that liquid waste from the dimension exl with lm instrument's cuvette waste bin splashed into a technologist's face.The customer also indicated that the top seal was leaking.The cse cycled over one hundred cuvettes and all sealed properly.The cse also ran system check and quality controls (qc), which recovered acceptably.Subsequently, the cse found that no more than seventy-five to one-hundred cuvettes in a row would seal properly.As a result, the cse replaced the top seal solenoid and adjusted the cuvette top seal assembly and associated sub-assemblies.Upon further investigation, siemens determined that the technologist did not wear protective eyewear or a face shield.The cse advised the customer to wear proper face and eye protection when emptying cuvette waste bin.The dimension exl with lm system operator's guide indicates the following: "the cuvettes and the contents of the cuvettes may present a biohazard or chemical hazard.Follow standard laboratory procedures for protection from biohazards and chemicals when performing maintenance and troubleshooting procedures." a use error contributed to the technologist's exposure to liquid waste.

• Brand Name: DIMENSION EXL WITH LM
• Common Device Name: DIMENSION EXL WITH LM
• 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 rd; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 16018495
• Report Number: 2517506-2022-00341
• Device Sequence Number: 12208556
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/20/2022

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
• Device Catalogue Number: 10472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2012
• 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: Female