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

Model Number VERSACELL X3

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Siemens noted that there was evidence of poor barcode labels.A customer service engineer (cse) was dispatched to the customer site to perform troubleshooting.The cse observed that a sample tube was picked up low on the tube and drop inside the system.The cse performed the following services and monitored the system's performance: replaced the f/o (fiber optics), r axis motor and gearbox, wrist assembly, and x-axis tg (tragentory generator).The system was verified and performed with no errors post-service repairs.Siemens reviewed the information provided, and the service performed and concluded that the x-axis tg replacement resolved the issue.The customer is satisfied with the service performed.The system was verified and operating as intended.No further evaluation of the device was required.Mdr 2247117-2021-00010 was filed for the same event.

Event Description

The customer informed siemens that the versacell x3 system dropped sample tubes.The customer reported that sample tubes were dropped inside the system and contaminated samples in the rack.There are no known reports of adverse health consequences due to the dropped sample tubes.

• Brand Name: VERSACELL X3
• Type of Device: VERSACELL X3
• 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; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 11529702
• MDR Text Key: 243743902
• Report Number: 2247117-2021-00009
• Device Sequence Number: 1
• Product Code: DGC
• UDI-Device Identifier: 00630414595177
• UDI-Public: 00630414595177
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSACELL X3
• Device Catalogue Number: 10793839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• 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