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 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the data received from the field, after the 4 sample tubes were diverted into the bioplex 2200 im, inpeco data management software correctly replied to the analyzer queries and communicated the test orders of each tube.After the first sample tube remained in the sampling position without receiving the complete message from the analyzer, the error messages "f30a sampling complete message not arrived timeout expired" and "f398 analyzer in error " were generated: as consequence of these errors by design the first tube is flagged with error and sent to the input output module priority output rack to be manually managed by the operators and the im is blocked.The operators recovered the error and manually loaded the 4 sample tubes on the analyzer to repeat the tests.The investigation is still ongoing: inpeco has asked for additional data to determine the root cause of the event in collaboration with the analyzer manufacturer.

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 and that the test results obtained from this tube were associated 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.

Manufacturer Narrative

Initial report submitted on october 6th, 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 corrective 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: 15549736
• MDR Text Key: 306884581
• Report Number: 3010825766-2022-00003
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)200515
• 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: 10/06/2022
• 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?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1