MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Missing Test Results (3267)

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

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) and reported that samples were processed on the connected analyzers and test results did not post on the centralink data management system.The customer became aware when the doctor's office called for results and was able to post the results without using centralink.Siemens is investigating.

Event Description

The customer informed siemens that an intact parathyroid hormone (ipth) result did not post in the centralink data management system.The customer noted that during 30 minutes, the centralink did not post results sent by the connected analyzers.There are no known reports of patient intervention or adverse health consequences due to the delay in posting a result in the centralink data management system.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2021-00085 on 23-mar-2021.Siemens filed the first supplemental mdr 2432235-2021-00085_s1 on 21-apr-2021.Additional information (28-apr-2021): siemens evaluated the log files for the reported issue and observed the sample ids in both the centralink data management system (dms) result channel and the laboratory information system (lis) outbound channel log files.Siemens concluded that a deadlock occurred due to the actions of accessing the database simultaneously.When a deadlock occurs, one of the processes must back down for a timeframe of 30 minutes.In this case, the dms result translator backed down for 30 minutes, which corresponds to the timeframe the customer reported samples not filing into the database and into the application.After the 30-minute deadlock timeout, it was observed that the translator began processing results without the operator or siemens service intervention.Siemens verified that the system is working as specified and with the manufacturer's claims in that one service must back down for a timeframe of 30 minutes by design in these cases.The system is operational post-service visit and operating as specified.No further evaluation of the device was required.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2021-00085 on 23-mar-2021.Additional information (30-mar-2021): the siemens customer service engineer (cse) retrieved the missing results for the customer.The cse reconfigured the upload command to allow time for the instrument to write results to the database.The cse monitored the uploading of results and observed no recurrence of the issue.The centralink data management system is performing within specification.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: CENTRALINK DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11557662
• MDR Text Key: 246772647
• Report Number: 2432235-2021-00085
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

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: CENTRALINK DATA MANAGEMENT SYSTEM
• Device Catalogue Number: 11312087
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 03/30/2021; 04/28/2021
• Supplement Dates FDA Received: 04/21/2021; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR