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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an unapparent delay occurred with one human chorionic gonadotropin patient result with an atellica sample handler prime instrument.The customer found the samples were not processed.The customer confirmed that there was no impact to patient care due to the delay.There were no known reports of patient intervention or adverse health consequence due to this event.
Additional Manufacturer Narrative
An outside of united states (ous) customer reported an unapparent delay with troponin and human chorionic gonadotropin patient results with an atellica sample handler prime instrument.The customer contacted the siemens customer care center (ccc) and a siemens remote services was able to speak with the customer.Siemens is investigating the issue.This report serves as a correction to report #2247117-2023-00006 filed on november 21, 2023.The fda reporting site in the previous report was incorrect and has been corrected in this report.
Additional Manufacturer Narrative
Correction (27-nov-2023): section d; brand name (d1), common device name (d2), product code (d2), and model number (d4) were corrected to reflect the correct product, atellica sample handler prime.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00308 on 22-nov-2023.Additional information (08-feb-2024): siemens further investigated and a review indicated the device management layer (dml) encountered an internal exception causing the module to turn off unexpectedly.In these cases, the module manager (mm) will detect that the dml is unresponsive and will restart.Upon restarting, any uncompleted tests would be canceled.In cases where the system does not return to normal operation automatically, the operator can turn mechanics off/on or restart the system and re-order the tests manually.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; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: eric so ; 511 benedict ave.; tarrytown, NY 10591 ; 2012144764
• MDR Report Key: 18192785
• Report Number: 2432235-2023-00308
• Device Sequence Number: 20342855
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 02/15/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 02/08/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 11/27/2023; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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