MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL SAMPLE MANAGEMENT SYSTEM

Model Number VERSACELL SAMPLE MANAGEMENT SYSTEM

Device Problem Component Falling (1105)

Patient Problem Venipuncture (2129)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

Three patient sample tubes were dropped by a versacell sample management system while being transferred to an immulite instrument for testing.The samples spilled and were cleaned by the laboratory staff, who wore personal protective equipment.The samples could not be processed by the instrument and new samples had to be obtained from the patients.The spilled contents from the dropped sample tubes did not contaminate any other samples scheduled for testing.There are no known reports of patient intervention or adverse health consequences due to the sample tubes being dropped by the versacell sample management system prior to being sampled by the instrument.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).During troubleshooting with the customer, it was determined that the versacell sample management system grippers appeared to be working as expected.There were no obstructions and all o-rings were in place.A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the x-direction server motor printed circuit board and adjusted the arm alignment.The cause of the dropped sample tubes is unknown.The versacell sample management system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Type of Device: SAMPLE MANAGEMENT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 3801407
• MDR Text Key: 19021827
• Report Number: 2247117-2014-00025
• Device Sequence Number: 1
• Product Code: DGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/15/2014

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: Other
• Device Model Number: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Device Catalogue Number: 030102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/08/2014
• 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