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 modules have been kept monitored and several cases of sample spillage on track profile have been observed.Some of these cases were due to sample tubes filled beyond the maximum allowed filling volume.Moreover, the investigation has highlighted that main lane return gates did not activate in the timeframe foreseen by design.This gate stops the carriers on the main lane to avoid any collision with the carrier coming from the internal u-turn secondary lane.After the gates replacement the cases of spillage decreased.The number of carriers diverted into these internal u-turns is higher than the number declared during the automation system layout definition.The higher number of carriers causes more frequent cases of jam and possible collision.The involved internal u-turns are under investigation by service personnel onsite.
Event or Problem Description
Several cases of sample spillage have been reported from the field at the exit of two 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 area.Sample residues have been found on the track profile, the investigation performed up to now did not provide any evidence of real cross contamination.No discrepant test results potentially caused by sample cross contamination have been identified.
Additional Manufacturer Narrative
The initial mdr (3010825766-2021-00002) was submitted on february 26th, 2021.Additional information: the investigation confirmed that the number of carriers diverted into the internal u-turn (iut) is higher than the number declared during the automation system layout definition.The installed iuts were not designed to manage this high workflow.There are 6 iuts where the sample spillage still occurs after the service interventions.These iuts will be replaced with a new version of the module adequate to manage an higher number of diverted carriers.There have been cases of sample spillage from tubes filled more than the maximum filling volume.These occurrences can be attributed to a user error only since the overfilled sample tubes should not be loaded on the automation system.The modules will be kept monitored after the replacement.

• Brand Name: FLEXLAB
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 11385950
• Report Number: 3010825766-2021-00002
• Device Sequence Number: 14578570
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1