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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem False Negative Result (1225)

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

Event Date 12/04/2014

Event Type  malfunction  

Event Description

A discordant, (b)(6) result of one patient sample was erroneously released by the centralink data management system.The result initially resulted as (b)(6).The sample was then repeated in duplicate, resulting (b)(6) on the first replicate and (b)(6) on the second replicate.When the centralink received the (b)(6) replicate result, it released it.The customer issued a corrected report to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, (b)(6) result.

Manufacturer Narrative

The cause of the discordant, (b)(6) result is unknown.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2014-00741 was filed on december 29, 2014.Additional information (12/17/2014): a siemens technical applications specialist (tas) was dispatched to the customer site.After evaluation of the instrument data, the tas discovered that the customer was not using the siemens (b)(6) algorithm configuration on their centralink and had the auto-validated rerun feature enabled.In this event, the initial reactive result was transmitted to centralink and a rerun was triggered, using the same sample id, which resulted as (b)(6) and was validated by centralink and transmitted to the laboratory information system (lis).The tas set the centralink to have all (b)(6) greater than or equal to one hold in review and edit.The configuration will prompt investigation of every (b)(6) and disable an automatic rerun.The configuration was tested and worked as expected.The cause of the (b)(6) is due to a software setup.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4364382
• MDR Text Key: 16453971
• Report Number: 2432235-2014-00741
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

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: 12/17/2014
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2015
• 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