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

Model Number ATELLICA DATA MANAGER

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

An outside united states (ous) siemens cse (customer service engineer) reported that the adm (atellica data manager with s/n: (b)(6), connected to dms (data management software), created an unknown patient id and replaced patient demographics with incorrect data and test results.Siemens investigated the event and noted the samples ran in the past, several months ago, and were archived as per system configuration.The customer noted no delay in testing and reporting results, and the event did not affect stat sample testing.The discordant results did not reach the customer lis (laboratory information system).On 11-dec-2023, siemens noted that results were sent from the ats1, causing dms to recognize them as unknown samples and create unknown patient ids.The samples were sent to adm, and it sent them to the lis with the real sample id but the unknown patient id.Since the samples already have a validated result on the lis, and no further results were requested, the system did not take the new results.Siemens is investigating the event.

Event Description

A siemens cse (customer service engineer) reported that the adm (atellica data manager with s/n: (b)(6), connected to dms (data management software), created an unknown patient id and replaced patient demographics with incorrect data and test results.There are no known reports of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2023-00339 on 27-dec-2023.Additional information on (28-feb-2024): siemens evaluated the information and confirmed that there was no atellica data manager (adm) malfunction and that the results were being sent from the atellica solution, as intended.The adm is working as intended, and there was no product problem.

• Brand Name: ATELLICA DATA MANAGER
• Type of Device: ATELLICA DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; registration #: 8020888; swords, co., dublin 10040 ; EI 10040
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 18401688
• MDR Text Key: 331510255
• Report Number: 2432235-2023-00339
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Model Number: ATELLICA DATA MANAGER
• Device Catalogue Number: 11314429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1