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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Missing Value Reason (3192)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer stated they ran the sample three (3) times on an advia 2120.The first sample flagged and triggered a rule that would send a flag to the customer's laboratory information system (lis), triggering a blood film creation.However, the sample was repeated to confirm results and the repeat run did not trigger the flag.Siemens is investigating the event.

Event Description

Customer reported that the slide maker stainer (sms) field was omitted by their centralink data management system, before a result was validated in the laboratory information system, causing a delay in treatment to a patient.There are no reports of adverse health consequences due to the delay in patient treatment.

Manufacturer Narrative

The initial mdr 2432235-2016-00772 was filed on (b)(6) 2016.Additional information ((b)(6) 2017): a siemens support implementation specialist was dispatched to the customer's site.The specialist explained how the rule worked to the customer.There was no issue found with the rule.The cause of the delay in treatment to a patient was human factor.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 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: 6179553
• MDR Text Key: 62539585
• Report Number: 2432235-2016-00772
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

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: 11/23/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• 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