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

Model Number VERSACELL X3 SAMPLE MANAGEMENT SYSTEM

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse retrieved the sample tube and tested it on all the racks, which read correctly.The cse verified that the racks were reading appropriately during normal operations and no error was detected.The cause of the sample barcode being misread is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The operator of a versacell x3 sample management system reported that a sample barcode was misread.A sample tube with accession # (b)(6) was read incorrectly as (b)(6).The original sample tube with accession # (b)(6) was read earlier on the same day.Sample tubes with accessions #s (b)(6) were not detected as duplicates.The error was observed after the sample was loaded and prior to any tests being assigned to the incorrect barcode.There are no known reports of patient intervention or adverse health consequences due to the sample barcode being misread.

Manufacturer Narrative

The initial mdr 2247117-2016-00078 was filed on november 18, 2016.Additional information (11/05/2016): a siemens customer service engineer (cse) revisited the customer site.The cse determined that the samples which fitted into the racks had the barcode partially hidden.The cse placed the samples with barcode exposed but the peripheral barcodes were not read.The cse then adjusted the barcode beam width and verified that the barcode reader was reading the samples normally.The instrument is performing within manufacturing 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: 6113105
• MDR Text Key: 60448378
• Report Number: 2247117-2016-00078
• Device Sequence Number: 0
• Product Code: CGJ
• Reporter Country Code: UK
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 11/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2015
• 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