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

Model Number AP2

Device Problem Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  Death  

Manufacturer Narrative

According to the analysis provided by the distributor, the missed transmission of the flags associated to the test results was caused by the wrong configuration of the stago sta r max interface module by the distributor service personnel who installed the wrong driver, the driver required to interface dms with stago sta r instead of the driver required for stago sta r max.The configuration error could have been detected by the service personnel during the tests after the installation or by the users since the analyzer name is displayed on the graphic user interface.The documentation made available to the service personnel for the interface module configuration and driver installation has been reviewed and confirmed to be clear and complete.The d-dimer test result is usually interpreted along with other test results to obtain the overall clinical picture.The d-dimer test result by itself should not lead to any therapeutic decision.A test result of 0 is not believable and should trigger a rerun in the validation phase.According to the evaluation of the haematologist on site the patients death was not caused by the automation system erroneous results transmission.According to the current information, the automation system has been confirmed not to be the cause of the incident.The investigation has been done based on the information provided by the distributor.The distributor has not provided yet inpeco with the log files necessary to confirm their analysis.

Event Description

The automation system data management software (dms) has sent to the upper middleware incorrect d-dimer test results associated to 13 sample tubes.The analyzer sta r max, manufactured by stago, sent to dms the d-dimer test results > 20 with the flag m (max), dms did not transmit the flag and reported to the upper middleware the out of range results as 0.According to the information received from the field 3 of these patients passed away.However the laboratory haematologist specified that the d-dimer results did not cause the patients' death.

Manufacturer Narrative

The initial report (3010825766-2021-00008) has been submitted on july 12, 2021.Supplemental report: per fda request, the product code has been corrected to dap.("fibrinogen/fibrin degradation products assay") which is the test product code for which the inaccurate results were generated.Additional information received from the distributor about the deceased patients.The initial reporter submitted the mdr 3007494875-2021-00001 on 21-jul-2021.No additional findings regarding the investigation have been communicated by the distributor.

Manufacturer Narrative

The initial report (3010825766-2021-00008) has been submitted on july 12, 2021.A supplemental report (3010825766-2021-00008_s1) has been submitted on august 2, 2021.Supplemental report: no additional findings regarding the investigation have been communicated by the distributor.The investigation has been completed with the confirmation that the automation system design is adequate.No further actions are foreseen.

• 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: 12150638
• MDR Text Key: 261001393
• Report Number: 3010825766-2021-00008
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)200408
• Combination Product (y/n): N
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 07/20/2021; 08/30/2021
• Supplement Dates FDA Received: 08/02/2021; 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death