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

Model Number	FLX
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3010825766-2021-00010
• Device Sequence Number: 4978468
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)200504
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: FLX
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown