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

Model Number AP2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

The event occurred at the bioplex 2200 interface module (im), which connects the third party's analyzer to the inpeco aptio automation track.The third party's analyzer is a "point of space", thus is able to sample the tube without removing it from the automation track.The customer reported that a sample tube at the sampling position of the bioplex 2200 interface module was aspirated 4 times by the third party analyzer, and that the test results obtained from this tube were associated by the third party analyzer also to the other 3 sample tubes in queue inside the im pit lane.The customer did not report any impact on the involved patients.Since the first event on oct 18, other occurrences happened in the same lab.

Manufacturer Narrative

Initial report submitted on nov 23 2022.Additional information: no evidence has been found of any issue of the automation system which is behaving according to the communication protocol with the analyzer.Based on inpeco's investigation, aptio automation was not a contributory cause of the incident.The investigation has not highlighted the need of any corrected action on the field.

• Brand Name: APTIO AUTOMATION
• Type of Device: 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: 15851238
• MDR Text Key: 307797883
• Report Number: 3010825766-2022-00007
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1