MAUDE Adverse Event Report: INPECO S.P.A APTIO AUTOMATION

Model Number APTIO AUTOMATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/02/2019

Event Type  Death  

Event Description

The customer alleged that there was a delay in obtaining a troponin (tnih) test result for a patient sample for approximately an hour on (b)(6) 2019.The customer reported that the patient expired while awaiting the troponin (tnih) result.The emergency room nurse followed up on the troponin results multiple times, making the operator aware of the delay.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.Siemens investigated the instrument files and determined that an initial panel of blood tests were ordered on the patient sample.A troponin test was subsequently ordered on the patient sample.Siemens determined that a sample tube with sid (b)(6) was returned to the aptio automation system (serial number: (b)(4)) on (b)(6) 2019 at 4:57:52 pm after being processed on an atellica instrument for the initial panel of results.The tube was sealed and sent to storage.At 6:41:48 pm, the sample was retrieved from storage, due to an add-on troponin (tnih) test that was subsequently ordered on the sample and processed at 6:48:55 pm.Then, the tube was sealed and sent to storage.At 7:38:43 pm, the sample was retrieved from storage and at 7:38:52 pm a de-sealer error sc021 "sample needs manual unseal - tube sealed too many times" was generated by the aptio automation system, as intended.The error caused the sample tube to route to a priority output lane for operator intervention at 7:39:30 pm, but was not reintroduced onto the track until 9:25:32 pm.The device is performing according to specifications, and there was no need for service or maintenance.Siemens is the importer of the medical device described.

Event Description

The initial mdr 3007494875-2019-00002 was filed on 20-dec-2019.Additional information (30-dec-2019): the manufacturer of the device submitted mdr 3010825766-2019-00014 on 30-dec-2019.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): INPECO S.P.A; via torraccia 26; registration #: 3010825766; novazzano, 6883 ; SZ 6883
• MDR Report Key: 9505082
• MDR Text Key: 172274582
• Report Number: 3007494875-2019-00002
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)190128(21)
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 12/20/2019,01/16/2020

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
• Device Catalogue Number: 11266636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR