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

Model Number	AP2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/23/2019
Type of Reportable Event	Death
Event or Problem Description
The customer alleged that there was a delay in treatment administration for a patient because there was a delay in obtaining hemostasis test results (prothrombin time, activated partial thrombin time, and fibrinogen) on a patient sample due to the aptio automation system.Based on the data provided by the customer, it is siemens understanding that the sample tube (id #(b)(6)) was loaded on the aptio automation system (serial number: (b)(4)), on (b)(6) 2019, for centrifugation and sorting.The operator indicated that the sample tube diverted to the centrifuge module (cm) at 3:10 a.M.And the automation system produced an error code "06b0" and a message "safety shield open" during the sample processing at 3:27 a.M.Based on siemens understanding, the sample was scheduled to run test methods (prothrombin time, activated partial thromboplastin time, and fibrinogen) on a non-siemens analyzer that is not interfaced to the automation system.The customer stated that the sample tube (id #(b)(6)) was an emergency tube, but it was not classified as a stat sample.The customer indicated that the patient result(s) were released to the physician(s) at 4:30 a.M.The customer reported that the patient expired at 4:40 a.M.On (b)(6) 2019.Siemens evaluated the log files and identified the error message "safety shield open", displayed on the user interface at 3:27 a.M., and was not cleared/reset for 23 minutes.It is siemens understanding that at 3:50 a.M.The centrifuge module (cm) returned to normal, and the patient sample tube returned to the automation track and was sent to the input/output module (iom) at 3:53 a.M.For the customer to load it on a non-siemens analyzer.Siemens confirmed the user is trained to use the automation system, and aware of the error condition that displayed on the user interface.The operator completed the error recovery, and the automation system was operational.The automation system at the customer site is functioning without issue, and there is no needed for service or maintenance.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.This mdr pertains to the same patient referenced in mdr 2432235-2019-00252, and the manufacturer (inpeco) filed mdr 3010825766-2019-00008 for this issue.
Event or Problem Description
Siemens filed the initial mdr 3007494875-2019-00001 on 16-august-2019.Additional information (22-august-2019): the customer informs that novoseven treatment was delayed.Siemens performed a follow-up with the customer, and the customer provides no additional information.

• Brand Name: APTIO AUTOMATION
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; 6883 ; SZ 6883
• MDR Report Key: 8901772
• Report Number: 3007494875-2019-00001
• Device Sequence Number: 2128248
• Product Code: CEM
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)190128
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019
• Report Date (Section F): 08/16/2019

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: AP2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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
• Patient Age: 70 YR
• Date Report Sent to FDA: 08/16/2019