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

Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Sample residues have been found on several track bypass modules (tbm) of flexlab as results of sample spillage.The tbm is a section of track where the carriers which transport the sample tubes are diverted to reach more quickly the needed modules/interface modules.The possible risk associated to this issue is the cross-contamination of another uncapped tube in the area where the tube spilled.The customer reported a case of sample tube potentially contaminated at the tbm#14 with consequent incorrect results.According to the customer, the sample tube with id (b)(6) was tested for thcg (human chorionic gonadotropin), and the result 111.10 was reported and questioned by the physician since it was not consistent with patient health conditions.The customer used another sample tube of the same patient to repeat the analysis on another siemens atellica analyzer, resulting in <2.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
According to inpeco investigation the sample id (b)(6) was never uncapped, so it could not be contaminated on the automation system.The sample tube contaminated could be sample id (b)(6), but it still to be confirmed from the field.According to the data analyzed, the sample id (b)(6) passed through one of the tbm where sample spillage has been found.Moreover, the sample tube has been tested for thcg on siemens atellica analyzer, giving the incorrect result.The incorrect result has been questioned by the physician, and no health impact on the patient has been reported.The investigation is still ongoing to determine the cause of the spillage.
Additional Manufacturer Narrative
Splashing issue was identified on several tbms on both systems: flx.0197 and flx.0198.The service personnel, guided by inpeco, checked the tbms (e.G.Transition of carriers to the turn disk, spinning time of t-module disk etc.).The service personnel performed troubleshooting procedures according to indications given in the service manual (e.G.Nsd device alignment) on all tbms.In addition the service personnel replaced polycord belts and disk on one tbm, and replaced the tbm with a straight track being the tbm unnecessary for the sample tubes routing in this specific layout section.The distributor, that is also the provider of service support at the customer location, confirmed that the splashing issue has been solved.No other actions foreseen at this customer.Inpeco has evaluated that no further action on field is needed, as the design is considered adequate.

• 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: 17708769
• Report Number: 3010825766-2023-00009
• Device Sequence Number: 2235880
• Product Code: CEM
• UDI-Device Identifier: 07640172340004
• UDI-Public: (01)07640172340004(11)181010
• Combination Product (Y/N): N
• 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): 12/20/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown