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

Model Number AP2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/02/2019

Event Type  Death  

Manufacturer Narrative

The log files analysis performed by the product distributor shows that the sample tube involved in the incident has been uploaded on the automation system at the 4:34:14 pm of (b)(6) 2019.The sample tube has been correctly processed at the analyzer and at the end of the tests, it has been sealed and at 4:58:59 pm it was routed to the storage and retrieval module (srm) in order to be kept in controlled conditions.At 5:57:49 pm the sample tube was retrieved from the srm due to an additional order received from laboratory information system (lis): the tube was processed as intended and at 6:10:58 pm it was placed again on the srm after being sealed.The same occurred at 6:41:48 pm and at 6:50:41 pm it was placed back in the srm after being sealed.The analysis shows that an additional order was received by lis and at 7:36:43 pm the sample tube was retrieved from srm for the third time: when the tube was diverted to the desealer module (dsm) at 7:38:52 pm (before being routed to the analyzer), the automation system generated an error message sc021 "sample needs manual unseal - tube sealed too many times".A sample tube is flagged with this error when it cannot be automatically desealed because the configured desealer maximum number of seals was exceeded.The error recovery foresees that the impacted tube is sent to a specific rack located in the priority output (po) in order to be visually inspected and manually managed by the laboratory technician.The analysis shows that at 7:39:30 pm the sample tube was in the rack waiting for operator intervention, but it was not introduced back on to the automation system until 9:25:32 pm.Inpeco automation system behaved according to specifications and there was no need for service or maintenance.The instructions for the error recovery are considered adequate, so no design change is foreseen: no field safety corrective action will be performed.

Event Description

The product distributor notified inpeco that on (b)(6) 2019 a patient arrived at the emergency room (er) of the hospital and expired.The patient had a tube classified as priority (stat) with a test order for troponin (tnih), the customer reported a delay for the troponin result of more than 1 hour.The emergency room nurse followed up on the troponin results multiple times, making the laboratory operator aware of the delay.The customer did not provide the cause of the patient expiring, nor the medications that were being taken at the time of the event.No information was provided about the possibility that a medical procedure was performed, delayed or withheld due to the delay.

• 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: 9529546
• MDR Text Key: 172995169
• Report Number: 3010825766-2019-00014
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)190301
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AP2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR