MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 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	Cancer (3262)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.The pump passed the functional test, including the stop (idle) current measurement test, run current measurement test, self test, off no power alarm test, a21 error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test, displacement test and dat at 0.0871 inches.The following were noted during visual inspection: scratched reservoir tube window and 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 was received without a battery.No damage noted on the battery cap.Please see below when reviewing the history download file.The pump was stored for an extended period without a battery.The pump was able to download the pump history file, but it was corrupted.There was multiple a47 alarm in the pump history due to corrupted history file.There was no data available on the event date 27-oct-2017 in the pump history file.Unable to verify bolus delivery, source of boluses delivered, daily insulin total and any alarms/suspends for event date 27-oct-2017 in the pump history file due to no data available.Unable to perform the history review 1 week prior to the event date 27-oct-2017 in the pump history file due to no data available.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly or on the motor.The pump passed the functional testing.Retainer ring damage confirmed (found cracked reservoir tube lip during visual inspection).A47 confirmed (found in the pump history file).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.
Event or Problem Description
It was reported to medtronic minimed that the customer passed away.The event involved product(s) mmt-723rnas.Troubleshooting was not performed.The reason for customer passing was cancer.It was unknown if the customer was using the insulin pump within 48 hours of the reported event.No further complications were reported.Mmt-723rnas was returned for analysis.

• 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 PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 23578470
• Report Number: 2032227-2025-301812
• Device Sequence Number: 13172083
• Product Code: OYC
• UDI-Device Identifier: 00643169513143
• UDI-Public: (01)00643169513143
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A1723RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 81 YR
• Patient Sex: Female