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); Erratic Results (4059)

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

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The advia centaur is a third-party analyzer not under inpeco responsibility, connected to the aptio automation system through an interface module.In the reported occurrences, the customer stated that a sample tube was diverted to the advia centaur interface module in order to be tested at the analyzer.The sample tube was released with the warning 3160 "sampling not successful" but with associated tests results.Due to the warning 3160 the sample tube was sent to a dedicated rack (priority output) of the input output module in order to be manually managed by the laboratory operator.The laboratory operator is a trained person on the use of the automation system, so he/she knows that when a sample tube is returned to priority output this means that an error is associated to the tube and it should be manually handled.The operator performed a rerun of the same tests loading the sample tube directly at the analyzer and he/she obtained results discordant from the initial ones.No impact on patient care was reported and the initial results were not reported to physician.The investigation is still ongoing to identify the root cause.

Event Description

The customer reported two occurrences about potential discrepant results obtained for sample tubes processed at the advia centaur analyzer connected to the inpeco aptio automation system.

Manufacturer Narrative

Initial mdr was submitted on november 18th, 2020.New information, february 25th, 2021: inpeco service department was in contact with the product distributor in order to collect all the information and perform the investigation.The distributor did not provide all the log files of the day of the event needed to know what happened to the involved sample tubes.Inpeco tried to reproduce the scenario in house, and no issue related to the inpeco product was identified.Missing log files prevent any further investigation; no other occurrence of the event was reported from the field.The codes present in section h6 are changed and updated according to supplemental information.

Manufacturer Narrative

The initial report (3010825766-2020-00008) was submitted on november 18th, 2020.The first supplemental report (3010825766-2020-00008_s1) was submitted on february 25th, 2021.Additional information: the issue reoccurred in another site, the provided data allowed to continue the investigation.According to the analysis, the firmware (fw) of the automation system interface module to advia centaur xp/xpt may lead, in specific and rare cases, to an incorrect association of test result(s) to sample id.The issue occurs as a consequence of a sample tube to be processed by the advia centaur xp/xpt that is not diverted into the interface module due to a mechanical issue or due to an obstruction.Upon this scenario, one of the following sample tube(s) that is diverted into the interface module in order to be processed by the advia centaur xp/xpt may be released from the interface module and flagged with the error code 3160 or 0d60 "sampling not successful" and with test results obtained from another sample tube.According to the default automation system configuration, the sample tube flagged with error code 3160 or the error code 0d60 is sent into an input/output module priority output rack to be manually managed by the operators.The root cause of the issue is a bug in the firmware of the automation system interface module to the advia centaur xp/xpt.Inpeco has released new firmware versions to correct the issue.The upgrade will be mandatory on the field for all the customers with the impacted interface modules.Inpeco has submitted the recall #3010825766- 090621 - 001 - c.

• 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: 10862129
• MDR Text Key: 250323491
• Report Number: 3010825766-2020-00008
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)180201
• Combination Product (y/n): Y
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1