MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL SAMPLE MANAGEMENT SYSTEM; GENERAL PURPOSE LABORATORY EQUIPMENT

Model Number VERSACELL SAMPLE MANAGEMENT SYSTEM

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

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

Event Date 01/07/2014

Event Type  malfunction  

Event Description

A patient sample tube was dropped by the versacell instrument upon transferring the sample tube to an immulite 2000 instrument for testing.The serum from the sample tube spilled, but did not contaminate any other patient samples.The operator cleaned the spilled serum.The patient whose sample tube was dropped required a redraw due to the serum from their sample tube being expelled when the tube was dropped.There are no reports of adverse health consequences due to the sample tube being dropped prior to being sampled.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the versacell sample management system and data, the cse determined that the robot arm used for transferring sample tubes required adjustment.The cse adjusted the robot arm assembly alignment.The system was run and the instrument was determined to be operational.The cause of the versacell sample management system dropping a sample tube was due to the robot arm mis-alignment.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Type of Device: GENERAL PURPOSE LABORATORY EQUIPMENT
• 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: john nelson ; siemens healthcare diagnostics; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3602575
• MDR Text Key: 17390081
• Report Number: 2247117-2014-00003
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023741
• 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: 01/08/2014

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: Health Professional
• Device Model Number: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 01/31/2014
• 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