MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2019
Type of Reportable Event	Death
Event or Problem Description
It was reported to medtronic minimed that the customer passed away on (b)(6) 2019.Cause of death was cancer and organ failure.Troubleshooting was performed and the pump was not worn at the time of passing.The last known product(s) for this customer are mmt-723rnas.Mmt-723rnas was requested and customer has returned the device.
Additional Manufacturer Narrative
The pump passed the displacement test, rewind test, basic occlusion test, prime/a33 test, excessive no delivery test and dat at 0.0871 inches.The stop (idle) current and run current measurement tests are within specification.The pump also passed self test, off no power alarm test and a21 error test.The pump alarmed motor error during the occlusion test due to faulty fsr (gold).The motor was tested outside of the pump and passed.The following were noted during visual inspection: cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thds and carelink upload was successful.The pump did not have a battery installed when received.No damage noted on the original battery cap.There was no data available in march 2019 in the pump history file.Unable to list the total insulin delivered on the event date 04-mar-2019 and the 7 days prior to that date due to no data available.Unable to verify bolus delivery, source of boluses delivered, daily insulin total and any alarms/suspends for event date 04-mar-2019 in the pump history file due to no data available.Unable to perform the history review 1 week prior to the event date 04-mar-2019 in the pump history file due to no data available.Unable to complete the functional testing due to motor error alarm.Motor error alarm confirmed during the occlusion test due to faulty fsr (gold).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: lusine boyadzhyan ; 18000 devonshire st.; northridge, CA 91325
• MDR Report Key: 20181278
• Report Number: 2032227-2024-235526
• Device Sequence Number: 8298466
• Product Code: OYC
• UDI-Device Identifier: 00643169221505
• UDI-Public: (01)00643169221505
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: Lay User/Patient
• Device Model Number: MMT-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A000290012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 65 KG