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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a few drops of the contents of the positive human immunodeficiency virus, hiv ag/ab quality control (chiv qc) material splashed onto the operator¿s hand and face while loading qc material onto the atellica sample handler prime.The operator was not wearing the appropriate personal protective equipment (ppe) and is suspected to be pregnant.Subsequently, the customer disinfected herself and thoroughly washed her hands and face and did not require medical attention.There are no known reports of adverse health consequences due to the event.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center and reported that a few drops of the contents of the positive human immunodeficiency virus, hiv ag/ab quality control (chiv qc) material splashed onto the operator's hand and face while loading qc material onto the atellica sample handler prime.Siemens further evaluated the event and concluded the operator did not follow the recommendations for wearing proper personal protective equipment (ppe) while operating the system as per the atellica solution operators guide.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Common Device Name: ATELLICA SAMPLE HANDLER PRIME
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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: 23848275
• Report Number: 2432235-2025-00320
• Device Sequence Number: 9599487
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/19/2025

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: 12/09/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2018
• 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: 33 YR
• Patient Sex: Female