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

Model Number	FLX
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported several cases of sample spillage along the track.Sample residues have been found on the track belt, track profile and on the safety covers.The event could lead to the cross-contamination of the other uncapped tubes that may be present in the area.According to the information provided from the field, no discrepant results have been reported and so far patient testing has not been affected.The investigation is still ongoing to determine the root cause of the sample spillage.
Additional Manufacturer Narrative
Information present in the initial report (#3010825766-2019-00010) are confirmed.Additional information: according to the investigation, the spillage occurred at the decapper modules and at the not stop divert of the track bypass modules (both in t and u configurations).The cases of spillage at the decapper module were caused by the presence on the automation system of unallowed tubes with rubber caps.No spillage occurred when approved tubes/caps were routed to the decapper module except for spill already foreseen and managed by the module design (e.G.Possible spillage in case of clot attached to the bottom of the tube cap).The cases of spillage at the track bypass modules were due to a high frequency of carrier jams on the track caused by a not optimized configuration of the queue length.The investigation showed that the track queue length was customized for this specific installation by inpeco service personnel before the automation system go-live, but then for a human error the default configurations were re-installed.The issue was solved restoring the optimized queue length configuration.The automation system has been monitored by service personnel on field: only further cases of sample spillage now happen for overfilled urine tubes.The customer is aware not to load tubes with a sample volume higher than the maximum acceptable volume.The automation system is working according to specifications.No further actions are foreseen.

• Brand Name: FLEXLAB
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 9391930
• Report Number: 3010825766-2019-00010
• Device Sequence Number: 19260223
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)181217
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: No Information
• Device Model Number: FLX
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1