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

Model Number APTIO AUTOMATION SYSTEM

Device Problem Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  Death  

Event 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
• Type of Device: APTIO AUTOMATION DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 12204318
• MDR Text Key: 262702482
• Report Number: 3007494875-2021-00001
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)200408
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: APTIO AUTOMATION SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2021
• Distributor Facility Aware Date: 06/30/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death