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

Model Number ATELLICA DATA MANAGER

Device Problem Communication or Transmission Problem (2896)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

One falsely elevated prostate specific antigen (psa) test result on one patient sample was reported to a physician(s) when the laboratory's labdaq laboratory information system (lis) mismanaged the "result aspect codes" it received from the atellica data manager (adm).The adm was reconfigured to not send "result aspect codes" and the correct psa test result was retransmitted from the adm to the labdaq.The retransmitted test result was reported to the physician(s) as the correct result.There are no known reports of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

The customer contacted siemens to report that one falsely elevated prostate specific antigen (psa) test result on one patient sample was reported to a physician(s) when the laboratory's labdaq laboratory information system (lis) mismanaged the "result aspect codes" it received from the atellica data manager (adm).A siemens customer service (cse) was dispatched to the customer site to inspect the adm.The cse deselected the option in adm to transmit "result aspect codes" to an lis and retransmitted the test result, resolving the event.Siemens evaluated the available information and found that when the adm transmits "result aspect codes" non-test result data (e.G., rlu and coff), is transmitted to the lis.The lis was improperly configured to manage "result aspect codes" and swapped a "result aspect code" for the actual test result.It was also found that adm to lis testing during adm validation used a "test" channel with "result aspect codes" deselected.When the customer went live with the adm a different channel was used and that channel was configured to send "result aspect codes".The cause of the falsely elevated psa test result was an adm configuration setting that was not supported by the lis.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

• 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; registration #: 8020888; chapel lane; swords, co, dublin 10040 ; EI 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 15156960
• MDR Text Key: 304798441
• Report Number: 2432235-2022-00213
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2022

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: 07/12/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2022
• 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
• Patient Age: 47 YR
• Patient Sex: Male