MAUDE Adverse Event Report: INPECO SA FLEXLAB; LABORATORY AUTOMATION SYSTEM

Model Number FLX

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The service personnel inspected the modules and checked the alignment of the no stop divert devices at the entry of the internal u-turn modules.The involved modules are kept monitored for further investigation.

Event Description

Cases of sample spillage have been reported from the field at the entry of some internal u-turn modules.This module provides a short way for carriers to reach their destination on the automation system by diverting them to a u-shaped lane connecting a portion of track with opposite flow direction.The sample spillage may cause cross contamination if the sample drops fall into another uncapped sample tube present in the queue or in the main lane.Sample residues have been found on the track profile.The investigation performed up to now did not provide any evidence of cross contamination.No discrepant test results potentially caused by sample cross contamination have been identified.

• Brand Name: FLEXLAB
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• Manufacturer (Section G): INPECO SPA; via givoletto 15; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 13309003
• MDR Text Key: 290072754
• Report Number: 3010825766-2021-00010
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)200504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1