MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK

Model Number CENTRALINK

Device Problem Missing Test Results (3267)

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

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) and reported that samples were not processed and circling the automation track.Siemens reviewed the information provided and noted that some processing occurred on the advia #2, and the sorting test (che) was set to run on advia #1 but did not process from the aptio automation system.Siemens performed troubleshooting and assisted the customer remotely.Siemens aligned the aptio time with centralink time and performed testing to verify that sample tubes were sorting correctly and not circling on the automation track.Siemens concluded that the cause of the communication issue was due to the aptio system clock that was not correctly syncing with centralink.The customer service engineer (cse) performed the appropriate configurations per the installation guide to sync the aptio time with centralink.The centralink system is operational and performing as expected.No further services were required.

Event Description

The customer informed siemens of a delay in testing patient samples.The customer reported that samples were not sorted correctly due to a communication issue with centralink.The customer informed siemens that patient samples had to be redrawn for testing purposes, and medical treatment was delayed.There are no known reports of patient intervention or adverse health consequences due to the delay in testing patient samples and a communication issue with the centralink.

• Brand Name: CENTRALINK
• Type of Device: CENTRALINK
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; registration number: 8020888; swords, co., dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 11809550
• MDR Text Key: 251209886
• Report Number: 2432235-2021-00120
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2021

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
• Device Catalogue Number: 10811597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/11/2021
• 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