MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL X3 SAMPLE MANAGEMENT SYSTEM

Model Number VERSACELL X3 SAMPLE MANAGEMENT SYSTEM

Device Problem Mechanical Problem (1384)

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

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse determined that the spring of the tube holder was defective.

Event Description

The operator of a versacell x3 sample management system reported that a sample tube was not placed properly and tipped over while returning to the versacell drawer.The contents of the sample tube spilled out potentially contaminating other tubes in the rack.The potentially contaminated tubes were discarded.New sample tubes were obtained from the patients, which lead to delay in reporting of results.There was delay in reporting of results for 30 minutes for sample ids (b)(6), while new sample tubes were obtained for patients with sample ids (b)(6) after 1 hour and 30 minutes.There are no known reports of patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The initial mdr 2247117-2016-00036 was filed on june 23, 2016.Additional information (05/31/2016): while a siemens customer service engineer (cse) specialist was at the customer site, the cse checked the alignment of the clamp on the drawer and wheel.It was determined that the customer runs the samples using the flange tubes.The customer is using a new drawer after the samples spilled in their previous drawer.Additional information (06/29/2016): a siemens headquarters support center (hsc) specialist reviewed the instrument data provided by the cse and indicated that the tubes which have a screw top, flange or protruding edges are not specified for use on the versacell x3 sample management system.

Manufacturer Narrative

The initial mdr 2247117-2016-00036 was filed on june 23, 2016.The first supplemental mdr 2247117-2016-00036_s1 was filed on july 22, 2016.Additional information (05/31/2016): the issue was resolved by replacement of the drawer.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: VERSACELL X3 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 road; flanders NJ 07836
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5746502
• MDR Text Key: 48102344
• Report Number: 2247117-2016-00036
• Device Sequence Number: 0
• Product Code: CGJ
• Reporter Country Code: FR
• PMA/PMN Number: K970227
• 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,Followup
• Report Date: 08/02/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSACELL X3 SAMPLE MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• 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