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
At the oum exit, the position of the sensor at the main lane return gates has been adjusted to correctly stop the carriers on the main lane avoiding any collision with the carriers which leaves the oum.The service personnel checked all the module and performed the needed fine-tuning and mechanical adjustments.After the service activities, the number of cases of sample spillage has significantly decreased.The remaining cases should be caused by sample tubes filled beyond the maximum allowed filling volume.The modules are kept monitored by service personnel currently onsite.
Event or Problem Description
The customer reported cases of sample spillage at the over under pass modules (oum).Specifically, sample residues have been found at the entry when carriers are diverted into the module secondary lane, at the corner of the secondary lane and at the exit of the module.The oum connects two areas of the laboratory through an overpass track portion.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 cross contamination.No discrepant test results potentially caused by sample cross contamination have been identified.
Additional Manufacturer Narrative
The initial report (3010825766-2021-00003) has been submitted on february 26th, 2021.Additional information: additional cases of spillage have been observed at the over-under pass module while the tubes are pushed by the mover on the entry bay.Sample residues have been found on the track profile behind the mover, there has been no evidence of cross contamination.No discrepant test results potentially caused by sample cross contamination have been identified.The movers have been aligned by service personnel on field and the issue has been fixed.Other scenarios described in the initial report are still under investigation.The modules are kept monitored.
Additional Manufacturer Narrative
The initial report (3010825766-2021-00003) has been submitted on (b)(6), 2021.The first supplemental report (3010825766-2021-00003_s1) has been submitted on (b)(6) 2021.Additional information: for the cases of spillage at the corner of the secondary lane of over under pass modules (oum) inpeco has identified as root cause an harware defect.Inpeco has installed belt beams connection brackets to facilitate the correct movement of the carriers along the oum secondary lane.The brackets were installed in all the oums of the impacted site and the modules have been kept monitored.No new cases of sample spillage have been observed.There were no other oum in use in any other laboratory.The section h6 (investigation findings and investigation conclusions) has been updated to include new codes.The problem of sample spillage at the entry and exit of oum is still under investigation.
Additional Manufacturer Narrative
The initial report (3010825766-2021-00003) has been submitted on february 26th, 2021.The first supplemental report (3010825766-2021-00003_s1) has been submitted on march17th, 2021.The second supplemental report (3010825766-2021-00003_s2) has been submitted on december 10th, 2021.Additional information: the investigation of the cases of sample spillage at the entry and exit of the over under pass modules (oum) has been completed.The sample spillage is caused by the return of the sample tubes on the main track which collide or create jams with the sample tubes passing on the main track due to the high number of carriers diverted into the oums at this specific customer site.Inpeco has released a kit with additional tube presence sensors to check the absence of any tube jam on the main track before releasing the sample tubes from the oum pit lane.The reduction of jam at the oum exit avoids also any collision of the sample tubes and possible spillage at the oum entry.This change will be implemented on all the oums installed in this site.No additional actions are foreseen.

• 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: 11386219
• Report Number: 3010825766-2021-00003
• Device Sequence Number: 17268838
• 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: SZ
• 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): 01/20/2022

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: 01/28/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 12/09/2021; 12/21/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/17/2021; 12/10/2021; 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown