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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that the patient was transferred to another hospital because the customer perceived the atellica sample handler prime to be unavailable.Siemens evaluated this event and determined the vessel mover module (vmm) auto-check daily maintenance failed on the day of the event.The customer restarted the auto-check; at this time, the laboratory information system (lis) was not connected, and a stat sample was not processed.Siemens further investigated the event and determined that it is expected that vmm auto-check maintenance will stop the atellica solution as the atellica sample handler and all connected analytical modules that are connected via the vmm need to enter a paused/stopped state for the vmm maintenance to start.With additional clarification from the customer, siemens determined that the operator was unfamiliar with the atellica solution at the time, surmised the instrument was unavailable, and sent the sample to an alternate hospital.The status of each module, including the vmm, is displayed on the main user interface workspace (uiw) screen as it transitions through the various modes needed to enter vmm daily maintenance.A service engineer inspected the instrument and replaced the gigabit switch as it was determined vmm was not receiving appropriate information and was timing out after receiving the auto-check request.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported auto check failed on the atellica sample handler prime.When the auto check was repeated, the laboratory information system (lis) was not connected, and a stat sample was not processed.The customer reported that since the analyzer appeared unavailable, a patient was reportedly transferred to another hospital.No further details were provided.The duration of the delay and impact to patient care are unknown.This mdr is being filed in an abundance of caution.

• 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: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 19986380
• Report Number: 2432235-2024-00181
• Device Sequence Number: 11852809
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 08/14/2024

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: 07/23/2024
• Initial Report FDA Received Date: 08/14/2024
• 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: Unknown