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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/19/2014

Event Type  malfunction  

Event Description

The operator of an advia 2400 instrument stated that a urea nitrogen result for one patient sample was incorrectly displayed on the centralink data management system.It is unknown if any of the results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant urea nitrogen result.

Manufacturer Narrative

The cause of an incorrect urea nitrogen result displayed on the centralink data management system is unknown.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2014-00443 was filed on july 15, 2014.Correction (07/16/2014): the customer did not report any of the results to the physician(s).

Event Description

The customer did not report any of the results to the physician(s).

Manufacturer Narrative

The initial mdr 2432235-2014-00443 was filed on july 15, 2014.2432235-2014-00443 supplemental 1 was filed august 14, 2014.2432235-2014-00443 supplemental 2 was filed october 09, 2014.Additional information (09/24/2015): siemens healthcare diagnostics has identified the following two issues using the centralink data management system.The first issue is that under certain conditions, the centralink data management system may apply the conversion factor twice when it has been configured to report results in a different unit from that received from the instrument (e.G.,the instrument reports in mg/dl and the centralink system displays and reports in g/dl).This behavior only applies to patient results.Quality control results are not affected.The second issue is when advanced rerun is used in centralink to order a manual dilution for a test that has been configured with a low detection limit in centralink and the result reported from the instrument is below the low detection limit, it will be reported as: <(value of low detection limit x manual dilution factor).A customer notification titles: "centralink data management system unit conversion issue" (b)(4) was sent to customers in september 2015.The customer notification informs customers of the issue, instructing customers to review and perform steps for each test method definition to ensure the centralink system is not performing unit conversions.When these issues occurs, the risk to health is negligible.Siemens is not recommending a review of previously generated results.

Manufacturer Narrative

The initial mdr 2432235-2014-00443 was filed on july 15, 2014.2432235-2014-00443 supplemental 1 was filed august 14, 2014.Additional information (09/16/2014): in an investigation conducted by siemens healthcare, it was discovered that the cause of the incorrect value of urea nitrogen displayed in the centralink data management system is due to a software issue.Under certain conditions, a result is converted twice instead of once, resulting in falsely low values.When the customer detects a falsely low value, they resend the result from the instrument, which then provides the correct value.

• 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 3936264
• MDR Text Key: 4600766
• Report Number: 2432235-2014-00443
• Device Sequence Number: 1
• Product Code: NSX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• 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
• Date Manufacturer Received: 09/24/2015
• 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