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

Model Number VERSACELL SAMPLE MANAGEMENT SYSTEM

Device Problem Mechanical Problem (1384)

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

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse adjusted the barcode position and verified racks and tubes were read.The cause of the barcode mismatch is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

The operator of a versacell sample management system reported barcode mismatching on the system.When the versacell scans a small or aliquot tube, it occasionally scans the large tube located behind the smaller tube.The verscell arm then picks up the larger tube and a duplicate barcode message is obtained.The customer stated there were no results reported which were questioned or corrected reports issued due to the barcode mismatch.There are no reports of patient intervention or adverse health consequences due to the barcode mismatch.

Manufacturer Narrative

The initial mdr 2247117-2016-00083 was filed on november 28th, 2016.Additional information (12/15/2016): a siemens headquarter support center (hsc) specialist evaluated the service data related to the event.The beams on the barcode reader assembly were adjusted to the to the right length or width during service so as not to overlap when reading a sample tube.There were no further incidents since service was performed.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Type of Device: CLINICAL CHEMISTRY 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6129894
• MDR Text Key: 60994484
• Report Number: 2247117-2016-00083
• Device Sequence Number: 0
• Product Code: CGJ
• Reporter Country Code: CA
• 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
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• 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
• Date Manufacturer Received: 12/15/2016
• 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