MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAB
Medical Device Problem Codes	Obstruction of Flow (2423); Battery Problem (2885); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose, flush drive support disk.Unable to perform prime, compromised force sensor system test, excessive no delivery test and occlusion test or verify no excessive no delivery alarm due to motor error alarm.Pump monitored for several days.Insulin pump received with normal operating current.No unexpected low battery alarm anomalies noted.Pump received with cracked case from display window corner, cracked case and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.
Event or Problem Description
Information received by medtronic indicated that the battery life of the insulin pump was shorter and had to change it in every 3 to 4 weeks.Customer had experienced battery draining and insulin pump dying when he first got warning of low battery.There was a crack in top right corner outside of screen by button.There were also no delivery alarms on the screen.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB
• 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
• MDR Report Key: 10446740
• Report Number: 2032227-2020-167482
• Device Sequence Number: 12295249
• Product Code: OYC
• UDI-Device Identifier: 00643169446434
• UDI-Public: (01)00643169446434
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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-723NAB
• Device Catalogue Number: MMT-723NAB
• Device Lot Number: B4723NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 55