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

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing and it is in charge of the product distributor.(b)(4) is in contact with the product distributor in order to receive the investigation findings.The customer did not report any impact on patient care due to the event.

Event Description

The aliquoter module has the aim to transfer sample from the primary tube to one or more secondary tubes.In case of clot detection error, the aliquoter module is foreseen to re-dispense part of aspirated sample in the primary tube.The customer noticed that the volume returned in the primary tube could be greater than the sampled volume: he supposed that a little amount of water from the aliquoter hydraulic circuit may be dispensed leading to sample dilution.

Manufacturer Narrative

The initial mdr 3010825766-2019-00011 was filed on december 13rd, 2019.Additional information (january 22th, 2020): the investigation was in charge of the product distributor who identified the root cause in an hardware component failure: the sample probe (i.E.Tip) was found bent.This could have caused the generation of the clot detection error because the tip of the aliquoter module was not able to aspirate correctly the sample.By design, in case of clot detection error, the aliquoter module is foreseen to re-dispense part of aspirated sample in the primary tube.In this event, it is likely that the module re-dispensed a little amount of water from the aliquoter hydraulic circuit, supposing to re-dispense the amount of sample.However, the primary tube is sent to priority output rack in order to be manually managed by the user, and the customer confirmed that no incorrect results were provided to physician.During the onsite visit for the investigation conduction, the service personnel replaced the aliquoter hydraulic circuit valve.No design change is expected for the hardware component.No further actions are foreseen.

• Brand Name: APTIO AUTOMATION
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 9465124
• MDR Text Key: 194319011
• Report Number: 3010825766-2019-00011
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1