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

Model Number ATELLICA DATA MANAGER (ADM)

Device Problem Data Problem (3196)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer contacted siemens to report that the atellica data manager (adm) received a test completed time stamp that indicated the test was completed before the sample was aspirated.The time stamp discrepancy was observed for the glucose test.The glucose test result was not reported as the discrepancy was noticed during validation.Siemens is investigating.

Event Description

The atellica data manager (adm) received a test completed time stamp that indicated the test was completed before the sample was aspirated.The time stamp was sent by the data management system (dms).The time stamp discrepancy was observed for the glucose test.The glucose test result was not reported as the discrepancy was noticed during validation.There are no known reports of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

The initial mdr 2432235-2022-00043 was submitted on 16-feb-2022.Additional information (05-may-2022): analyzer log files from the day of the event were requested for evaluation but were not available.The cause of the atellica data manager (adm) receiving a test completed time stamp that indicated the test was completed before the sample was aspirated is unknown.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: 13544317
• MDR Text Key: 286505022
• Report Number: 2432235-2022-00043
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 05/13/2022

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 (ADM)
• Device Catalogue Number: 11314239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: No
• 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