MAUDE Adverse Event Report: INPECO SA APTIO AUTOMATION SYSTEM; APTIO AUTOMATION DATA MANAGEMENT SYSTEM

Model Number	APTIO AUTOMATION SYSTEM
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2021
Type of Reportable Event	Death
Event or Problem Description
The customer contacted siemens to report that flagged d-dimer test results (an m flag signifying a result >20) were obtained from a non-siemens instrument and were transmitted to a non-siemens aptio automation data management system (dms).The dms sent a result of 0 (zero), and no m flag, to upstream middleware and a laboratory information system (lis).The customer indicated that this scenario occurred on three patients who later expired.The laboratory's hematologist stated the d-dimer test results did not cause the patients' expiration.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.The legal manufacturer, inpeco sa, filed mdr 30108257766-2021-00008 with the fda on 12-jul-2021.

• Brand Name: APTIO AUTOMATION SYSTEM
• Common Device Name: APTIO AUTOMATION DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 12204318
• Report Number: 3007494875-2021-00001
• Device Sequence Number: 3802525
• Product Code: LXG
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)200408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2021
• Report Date (Section F): 07/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: APTIO AUTOMATION SYSTEM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Date Report Sent to FDA: 07/21/2021