MAUDE Adverse Event Report: INPECO SA FLEXLAB; TOTAL 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 investigation is still ongoing to fix the issue.A mechanical fine tuning of the track bypass modules components has been evaluated necessary.The service personnel will monitor the situation to verify if, after the foreseen mechanical adjustments, the spillage does not occur anymore.
Event or Problem Description
Cases of sample spillage have been observed at the track bypass modules (tbm).The tbm is a section of track where the carriers that transport the sample tubes are diverted to reach the needed modules/interface modules more quickly.The possible risk associated to this issue is the cross-contamination of another uncapped tube in the area where the tube spilled.The customer did not report any actual case of test results potentially impacted by a possible cross-contamination.The users and the service personnel did not come in contact with the spillage thanks to the track covers.The track cleaning was done with ppe.
Additional Manufacturer Narrative
The initial report was submitted on october 23rd, 2020.Additional information: service personnel inspected the track bypass modules (tbm) where cases of sample spillage occurred.They performed mechanical adjustments on the modules components such as the followings: the track belts have been tensioned or replaced if needed.The disk speed has been checked and corrected adjusting the polycord belt.The gates paddles and the carrier presence sensors positions have been checked and corrected.The gate assembly has been replaced if needed.The sample spillage issues have been fixed in all the involved tbms except for 2 modules on which the service personnel is still investigating.The customer still did not report any actual case of test results potentially impacted by a possible cross-contamination.The modules are kept monitored.
Additional Manufacturer Narrative
The initial report (3010825766-2020-00007) was submitted on (b)(6)2020.The first supplemental report (3010825766-2020-00007_s1) was submitted on (b)(6) 2021.Additional information: service personnel has investigated the problem of sample spillage at the 2 track bypass modules (tbm) where new occurrences are still reported.For the tbm where the u-turn module is installed on the long section of t-module, inpeco released a kit with a straight track profile to be installed between the u-turn module and the t-module in order to avoid unnecessary change of directions of the sample tubes.At present the issue has not been reported from any other laboratory.No other actions foreseen for this tbm.For the other impacted tbm, the number of occurrences has decreased after the golive of other modules which allowed the reduction of the sample tubes diverted into the tbm and a better distribution of the sample tubes on the track.Additional actions are under evaluation to modify the layout and fix the issue.The section h6 (investigation findings and investigation conclusions) has been updated to include new codes.
Additional Manufacturer Narrative
Additional information: new cases of spillage have been observed from the last impacted tbm (track bypass module).It has been decided to remove this tbm since the actual workflow in this laboratory did not require the presence of a tbm (there was no need to route back the carriers).The tbm will be replaced with a straight portion of track.No other actions foreseen for this tbm.

• Brand Name: FLEXLAB
• Common Device Name: TOTAL 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
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 10726701
• Report Number: 3010825766-2020-00007
• Device Sequence Number: 16972336
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)180903
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Followup,Followup
• Report Date (Section B): 04/29/2022

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: 09/25/2020
• Supplement Date Received by Manufacturer: 04/28/2021; 11/12/2021; 04/27/2022
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 05/07/2021; 12/10/2021; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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