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

Model Number	AP2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inpeco has investigated the event identifying a problem of samples id mismatch.In the following scenario: the srm is retrieving a sample tube (tube a) in order to perform additional test orders.Another sample tube (tube b) is erroneously not deviated into the srm pit lane due to a malfunction of the gate.The tube a is released by the srm as tube b due to a miscommunication between the srm firmware and the automation software.In the case reported from the field tube b did not have pending test orders so both the sample tubes (the real tube b and the tube a wrongly identified as tube b) were directly sent to the srm.There was a delay in the additional tests ordered on tube a since the automation system loses the traceability of this sample tube.The additional test orders remained pending on the automation software and there was already available another sample tube of the same patient to complete the tests.The investigation is still ongoing to identify possible additional impacts caused by samples id miscommunication in the scenario described above and possible other modules impacted by the same bug.
Event or Problem Description
The customer reported that, when they ordered the retrieve of a sample tube from the storage and retrieval module (srm) of the aptio automation, the sample tube was lost.The storage and retrieval module stores sample tubes from the automation system in a temperature controlled and protected environment.The event caused a delay in the execution of additional tests ordered on the sample tube.The customer did not report any consequence on the state of health and medical treatment of the involved patient.
Additional Manufacturer Narrative
The initial report (3010825766-2022-00006) was submitted on october 28th, 2022.Additional information: the investigation confirmed that the event is caused by a firmware bug.For all the impacted modules the issue will be fixed with a new firmware version and the upgrade will be mandatory on the field.Inpeco has submitted a correction and removal report to fda related to this issue (reference code: 3010825766 - 03/03/23 - 001 - c) upon the release of fixing firmware versions.

• Brand Name: APTIO AUTOMATION
• 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: 15690358
• Report Number: 3010825766-2022-00006
• Device Sequence Number: 7337870
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)201130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: SZ
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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
• Device Model Number: AP2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 03/03/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown