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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Human Factors Issue (2948)

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

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contracted a siemens technical service (tse) specialist.The customer gave permission for the tse to remotely dial into the instrument.The tse found that the sample was sent from a sister hospital and used within centralink.The tse found that the samples were duplicate sample ids from the laboratory information system (lis) test system and not production.The tse instructed the customer that when connecting to the lis test area, all test patients should be purged before returning to production interface.The cause of the wrong results being associated with wrong patients was due to human error.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The test results of one patient sample were associated with an incorrect patient sample on a centralink data management system.The customer received an order on (b)(6) 2016 for a patient with identifier "(b)(6)" with a sample id of (b)(6).Centralink omitted the order on this sample since it was not an "(b)(6)" identifier patient and centralink is configured to omit samples with patient identifiers not associated with (b)(6).The omitted sample remained in the centralink database.Samples with an omitted status remain in the database until they are purged.On (b)(6) 2016, new orders came in for a patient with the same sample id (b)(6), and were rejected by centralink because it was a duplicate sample id and a mismatch.The sample was placed on an automation track and was routed to the incomplete rack due to no orders.The customer then manually programmed the sample to run and results were sent to the centralink.Since the only sample in the database was the sample from (b)(6), centralink associated the results of the patient sample from (b)(6) 2016 to the patient from (b)(6) 2016.There are no reports of patient intervention or adverse health consequences due to test results being associated with the incorrect patient.

• 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5770214
• MDR Text Key: 48816721
• Report Number: 2432235-2016-00357
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/05/2016

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: 06/08/2016
• Initial Date FDA Received: 07/05/2016
• 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