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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The ccc contacted the regional service center (rsc).The rsc found the mispl filter to be incorrect.The rsc removed the mispl filter.The customer ran a patient sample and confirmed this corrected the issue.The cause of the cardiac troponin sample not being flagged as critical was due to the mispl filter not properly being set.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported that critical cardiac troponin test result was not properly flagged on their centralink data management system.The physician(s) as a result, were not called to review the result.The initial result was reported out to the customer.The customer did not repeat the sample.There are no known reports of patient intervention or adverse health consequences due to the result not being flagged as critical.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICSMANUFACTURING LTD; registration #: 8020888; chapel lane; swords, co, dublin 10040 ; EI 10040
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6324359
• MDR Text Key: 67326536
• Report Number: 2432235-2017-00113
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/10/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/10/2017
• 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
• Patient Age: 54 YR