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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported sustaining a cut on their ring finger while attempting to adjust the springs on the underside of the sample handler drawer, which was not closing properly on an atellica sample handler prime.The customer was sent to the emergency room (er), where the wound was cleaned and glued together with a medical-grade adhesive material.The customer recovered with no lasting effects.There are no known reports of adverse health consequences due to the reported event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported sustaining a cut on their ring finger while attempting to adjust the springs on the underside of the sample handler drawer, which was not closing properly on an atellica sample handler prime.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse observed that the drawer was stuck in the open position, the soft close slide was disengaged, the dampener was stuck in the up position, and the dampeners on drawers 3 and 4 were disengaged.Next, the cse reengaged the soft close slide, dampener, and the dampeners on drawers 3 and 4.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00281 on 27-oct-2025.Additional information (27-oct-2025): the customer was performing troubleshooting on their own before siemens was notified of the reported event.The atellica solution online help or operator¿s guide does not contain any guidance or instructions for operators to access the bottom of the sample handler (sh) drawers for troubleshooting.Only trained service personnel should access the bottom of the sh drawers for troubleshooting or repair.During the service visit, the customer service engineer (cse) observed that the drawer issue was caused by the customer opening the drawers too far.Siemens evaluated the event and determined that the customer sustained a cut on their ring finger due to performing troubleshooting on their own.Investigation findings and investigation conclusions codes of section h6 were updated to reflect the additional information.The system is performing within specifications.No further evaluation 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23389134
• Report Number: 2432235-2025-00281
• Device Sequence Number: 10047119
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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: Male