MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA DATA MANAGER

Model Number	ATELLICA DATA MANAGER
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	11/14/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A customer reported that an unapparent delay occurred with three troponin and one human chorionic gonadotropin patient results 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
Correction (22-nov-2023): this report was filed under the incorrect fda reporting number.A separate report was sent under mdr 2432235-2023-00307 to capture the same event but with the correct reporting number.

• Brand Name: ATELLICA DATA MANAGER
• Common Device Name: ATELLICA DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; 62 flanders bartley rd; registration #: 2247117; flanders 07836
• Manufacturer Contact: eric so ; 511 benedict ave.; tarrytown, NY 10591 ; 2012144764
• MDR Report Key: 18191607
• Report Number: 2247117-2023-00005
• Device Sequence Number: 17913183
• Product Code: JQP
• 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
• Report Date (Section B): 11/22/2023

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 DATA MANAGER
• 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
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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