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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.Review of the sample showed that it was clotted.The ccc reviewed the instrument data and found that the instrument had a normal setting of -1 for alkaline phosphatase.The ccc reviewed the normal ranges and found the instrument was not set up to hold a result of <10.The customer added 10 as the low limit on normal evaluation orders.The ccc testing the instrument and a result of <10 was held in review.The cause of the depressed, less than ten alkaline phosphatase result being released is due to human error, a setting was not set.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Customer reported that a depressed, less than ten (<10) alkaline phosphatase result was not held in review and was auto-validated by their centralink data management system.The initial result was released to the physician(s), which was questioned.The patient was redrawn and tested, resulting within the expected range and clinical picture of the patient.A corrected report was issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the depressed, less than ten alkaline phosphatase result being released.

• 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: 6207650
• MDR Text Key: 63368624
• Report Number: 2432235-2016-00812
• 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: 12/27/2016

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: 12/01/2016
• Initial Date FDA Received: 12/27/2016
• 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