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 checked the tbm entry not stop divert gates and performed the needed fine-tuning and mechanical alignments.The cases of spillage at the tbm entry have decreased and the modules have been kept monitored.At the tbm exit the spillage occurs: if the track profile does not correctly guide the carrier towards the module exit causing a slowing down of the carrier which could be hit by the other carriers behind.If the gate in the secondary lane which should stop the carrier to prioritize the passage of the carrier coming from the tbm is not activated in time causing the collision of the carriers.The service personnel is checking the track profiles, the gates activation timing and the firmware configurations to improve the tmb modules performance.
Event or Problem Description
Several cases of sample spillage have been reported when carriers with uncapped tubes are diverted into the track bypass modules (tbm), when the carriers pass from belt to tbm disk and at the module exit in case of collision with the carriers coming from the secondary lane.The track bypass module is a 90-degree bend section of the track which provides a short way for sample tubes to reach their analyzer or automation module destination.The two portions of tbm track are linked by a rotating disk.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 (3010825766-2021-00004) has been submitted on february 26th, 2021.Additional information: a case of sample contamination has been reported on one internal u-turn kept monitored by service personnel on site.The wrong firmware configuration at one of the track bypass modules (tbm) caused a carriers queue till the internal u-turn module upstream.A carrier was forced into the u-turn and was hit by the next carrier diverted into the module.The collision caused some spillage from the first tube which contaminated the second tube.The log files have been analyzed to trace where the contaminated tube was routed.The tube was sent to the aliquoter module and then to the high volume storage.The secondary tube obtained from the contaminated tube was sent to the input/output module and unloaded from the automation system.No tests have been performed on these tubes while they were still on the automation system.The customer has been informed about the event to determine how to manage the involved tubes and to assess the impact for any test potentially executed off-track.The customer did not report any consequence on the health condition and health status of the involved patient.The firmware configuration of the tbm has been corrected.No other occurrences have been reported.Other scenarios described in the initial report are still under investigation.
Additional Manufacturer Narrative
The initial report (3010825766-2021-00004) has been submitted on february 26th, 2021.The first supplemental report (3010825766-2021-00004_s1) has been submitted on march 18th, 2021.Additional information: the sample spillage at the track bypass module (tbm) entry has been fixed thanks to the fine-tuning and mechanical alignments performed by service personnel on the no stop divert gates.Occurrences of sample spillage were still reported on one tbm where the volume of diverted sample tubes is higher than the expected one.Inpeco released a track profile to bypass the no stop divert of this tbm and force all the sample tubes to take the long path.The sample spillage at the tbm exit has been fixed by the alignment of the anti-pinching gates which stop the carrier in the secondary lane to prioritize the passage of the carrier coming from the tbm.The modules have been kept monitored and no additional cases have been reported.

• 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: 11386370
• Report Number: 3010825766-2021-00004
• Device Sequence Number: 17268839
• 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,Followup
• Report Date (Section B): 12/10/2021

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: 01/28/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 11/12/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/18/2021; 12/10/2021
• 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