MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an operator obtained a shock when she touched the lower left back plate of the atellica sample handler prime instrument.The customer alleged that as a result of the shock, the operator experienced pain in her left arm.Upon further clarification, the customer informed siemens that the operator did not seek medical attention and is fine.There are no known reports of adverse 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
An outside of the united states (ous) customer contacted a siemens customer care center.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse performed an instrument grounding and leakage inspection.The inspection focused on verifying the integrity of ground connections, measuring earth bond resistance, and identifying any potential issues affecting electrical safety.It was determined that the relative humidity in the lab was low and out-of-specifications, the fans' mounting plate was loosely tightened on the atellica sample handler chassis, which could potentially affect the quality of the electrical grounding of these components.The screws were subsequently tightened to ensure proper contact and grounding.The cse did not find any electrical measurement values indicating a grounding issue.Both the earth bond tests and the continuity tests were found to be acceptable.Siemens further evaluated the event and concluded that that the shock felt by the user at the back of the atellica sample handler was the result of electrostatic discharge (esd) due to user-buildup of static electricity, out-of-operating-specification relative humidity in the laboratory, and the loose hardware used to mount the rear fan plate to the chassis.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Common Device Name: ATELLICA SAMPLE HANDLER PRIME
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 21509839
• Report Number: 2432235-2025-00074
• Device Sequence Number: 12753169
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161954
• 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): 03/03/2025

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: ATELLICA SAMPLE HANDLER PRIME
• Device Catalogue Number: 11069001
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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: 30 YR
• Patient Sex: Female