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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens technical support technician (tst) reviewed the event.The tst checked the test norms settings, and they were correct.The tst had the customer find a sample identification number and enter it into their centralink system.The tst reviewed the revision and edit screen and found no severities were triggered.The tst requested the customer to open the method on the instrument icon, but the customer stated there was no icon.The tst then request the customer to open the test for ptt.The tst found that the auto-validation for norm severity (ns) was set to 2.The norm is set to 9 severity.It is unknown who changed to setting to 0 as log auditing was not enabled at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse worked through multiple settings and found settings for the norm severity was set to 0.The cse corrected the setting to 9.The customer's technician ran samples to verify correction.The instrument was properly auto-validating samples and holding samples according to severity settings.The cause of the elevated partial thromboplastin time results auto-validating was due to centralink's norm severity setting being improperly set.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Multiple elevated partial thromboplastin time (ptt) results were auto-validated in a customer's centralink data management system.The customer supplied one result for one patient sample.The initial result was not reported out to the physician(s).The sample was not repeated.There are no reports of patient intervention or adverse health consequences due to the elevated partial thromboplastin time results being auto-validated.

• 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: 6015797
• MDR Text Key: 56990270
• Report Number: 2432235-2016-00610
• 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: 10/10/2016

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: 09/15/2016
• Initial Date FDA Received: 10/10/2016
• 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