MAUDE Adverse Event Report: THERMO FISHER SCIENTIFIC OY THERMO SCIENTIFIC¿ TCAUTOMATION¿; LABORATORY AUTOMATION SYSTEM

Model Number TYPE 1020

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation results it was determined that after the tube for sample a was placed in the centrifuge module load rack, the operator stopped the centrifuge module but did not remove all the samples as required per the instructions in the user manual.The operator then started the centrifuge module by releasing the module lock but did not remove all the samples prior to releasing the module lock as required per the instructions in the user manual.The tcautomation software performed as designed by correctly identifying the sample identification (sid) mismatch by posting a cross check error message.The results of the investigation did not identify any failures with the system.

Event Description

A customer reported that test results from a patient sample processed on the thermo scientific¿ tcautomation¿ laboratory automation system were mis-associated with the sample identification number (sid) of a different patient.Mis-associated patient results may lead to inappropriate physician action.The mis-associated patient test result was reported from the laboratory.There is no allegation of patient harm as a result of this event.The tcautomation software correctly identified the sid mismatch by posting a cross check failure message, as designed.This report corresponds to thermo fisher scientific oy complaint number (b)(4).

• Brand Name: THERMO SCIENTIFIC¿ TCAUTOMATION¿
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): THERMO FISHER SCIENTIFIC OY; ratastie 2; vantaa, 01620 ; FI 01620
• Manufacturer Contact: katja eronen ; ratastie 2; vantaa, 01620 ; FI 01620
• MDR Report Key: 8761877
• MDR Text Key: 150262489
• Report Number: 9610942-2019-00004
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2019

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: No Information
• Device Model Number: TYPE 1020
• Device Catalogue Number: 952040
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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