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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while determining why the vessel mover module (vmm) on the atellica sample handler prime unexpectedly halted, the operator removed carriers from the instrument.As the operator removed the magnetic carriers from the vmm, the operator pinched her fingers between the carriers.The operator reportedly bruised her ring and middle fingers, causing them to swell; additionally, the customer shared that there was a blister on the operator¿s middle finger.The operator went to the emergency room (er), where her finger was iced and bandaged.Additionally, the operator was given anti-inflammatory medication and an antibacterial lotion.There was no exposure to biohazardous material.There are no known reports of adverse health consequences due to the event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported an operator pinched her fingers between carriers from the atellica sample handler prime.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse determined that a sample tube dropped on the vessel mover module (vmm), which caused one of the gates to not close and open correctly.The cse removed the sample tube, cleaned the spill, removed, cleaned and reinstalled the rest of the carriers (pucks), and rebooted the vmm and atellica sample handler.The atellica solution online help warns operators with a carrier pinch hazard, which indicates ¿do not remove the carriers from the atellica magline transport.The carriers have strong magnets in the base and handling them in close proximity to metal objects can result in a body part being pinched between the carrier and the metal object.Only authorized service personnel should handle carriers.¿ siemens further evaluated the event and concluded that when the operator lifted one of the carriers off the track surface during movement, which created a high magnetic attraction to either another carrier or some other metal surface, potentially contributed to the event.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 avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 19977551
• Report Number: 2432235-2024-00179
• Device Sequence Number: 7057488
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/13/2024

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: 07/21/2024
• Initial Report FDA Received Date: 08/13/2024
• 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: Female