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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that while troubleshooting the jammed moving carrier on an atellica sample handler prime, the operator pinched their knuckle.The customer stated that they removed a tube from the tube characterization station (tcs) portion of the magline that prevented puck movement.The customer attempted to move pucks but while moving, two pucks stuck together.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the magline was in diagnostic state, the cse observed that two pucks were stuck together and sitting on top of the chemistry module.The cse exited diagnostics and powered off the magline.The cse verified that all obstructions were clear on the track, pulled apart the two pucks that were stuck, and returned them to the track.Further, the cse verified all gates were clear, and restarted the magline, and it entered a ready state.The atellica solution online help warns operators with a carrier pinch hazard which indicates that 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 the operator attempted to remove the carriers at the back of the system to save time in sliding the carriers along the magline track path potentially contributed to the event.When sliding the carriers along the magline track path sections, the magnetic fields between carriers repel each other, and under normal circumstances, would not snap together.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that while troubleshooting the jammed moving carrier on an atellica sample handler prime, the operator pinched their knuckle.The operator observed a tube obstructing the magline near the tube characterization station (tcs).The operator removed the tube and attempted to move the pucks away from the gates.While moving pucks through the back of the magline behind the decapper, two pucks snapped together and pinched their knuckle.This caused a small cut on their hand.The operator did not seek any medical treatment or intervention, and the operator was working fine.There are no known reports of adverse health consequences due to the event.

• 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; flander NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22165565
• Report Number: 2432235-2025-00146
• Device Sequence Number: 15766783
• 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): 06/09/2025

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: 05/16/2025
• Initial Report FDA Received Date: 06/09/2025
• 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: Unknown