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
Event or Problem Description
Sample residues have been found at the exit of the wide belt carrier buffer modules (wbb) where the sample tubes previously parked in the module buffer returned on the pit lane.The wide belt carrier buffer module is a sample carriers collector that provides the capability to relieve the track workload.The sample spillage may have caused the contamination of other uncapped sample tubes present in the area.So far no cases of actual cross contamination have been identified.
Additional Manufacturer Narrative
The investigation is ongoing to determine the root cause and to identify how to fix the issue.The wbb modules are kept monitored.
Additional Manufacturer Narrative
The investigation is ongoing to determine the root cause and to identify how to fix the issue.The wbb modules are kept monitored.
Event or Problem Description
Sample residues have been found at the exit of the wide belt carrier buffer modules (wbb) where the sample tubes previously parked in the module buffer returned on the pit lane.The wide belt carrier buffer module is a sample carriers collector that provides the capability to relieve the track workload.The sample spillage may have caused the contamination of other uncapped sample tubes present in the area.So far no cases of actual cross contamination have been identified.
Additional Manufacturer Narrative
The initial report has been submitted on december 10th, 2021.Additional information: the investigation has been completed.The root cause of the sample spillage at the wide belt buffer (wbb) exit has been identified in the specific traffic conditions, workflow and layout configuration present in this site.To solve the problem the speed values of the wbb belts which carry the carriers from the buffer to the module pit lane have been modified to improve the confluence of the carriers on the track.After this change the modules have been kept monitored and no further occurrences have been observed where the sample tubes return on the module pit lane.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: 12974604
• Report Number: 3010825766-2021-00011
• Device Sequence Number: 17216400
• 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): 02/24/2022

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): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 02/24/2022
• 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