MAUDE Adverse Event Report: INPECO SA FLEXLAB; LABORATORY AUTOMATION SYSTEM

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the analysis, the resuspension of the corpuscular cells is not due to the abrupt aspiration phase, but due to the pre-mixing option, available by default on the pipettor of the aliquoter module.The aliquots are tested on a third party instrument for coagulation tests.The results could be altered by the presence of cells (e.G.Platelets) impacting the precision of the test.The root cause of the event is the pre-mixing option of the aliquoter module's pipettor.The pre-mixing option has been disabled in the new firmware version of the aliquoter module, in order to avoid the pre-mixing step before the aspiration and dispensing process.The new firmware has been released by inpeco, and installed in the laboratory impacted by the issue.The laboratory impacted by the issue is the only customer having installed the aliquoter module with the firmware version affected by the problem, and using the aliquoter module for diagnostic purposes.
Event or Problem Description
The customer reported that the aspiration of the robot of the aliquoter module of flexlab is quite abrupt, and causes turbulence in the sample tube.The citrate tubes for the coagulation don't have a gel layer; therefore the centrifuged cells can be resuspended if the aspiration forces are too strong.The consequence is the creation of aliquots containing corpuscolar particles, that could give incorrect results, as the cells are measured along with the plasma.

• 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: 19936807
• Report Number: 3010825766-2024-00003
• Device Sequence Number: 4952884
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)231218
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown