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

Model Number MMT-723NAP

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Information received by medtronic indicated that insulin pump received motor error alarm.Customer stated drive support cap was flushed.Insulin delivery was temporarily stopped to ensure safety.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the displacement test.Device received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform prime/a33 test, excessive no delivery test and occlusion test due to motor error alarm.The drive support disk was inspected and found loose or protruded.Device received with cracked reservoir tube lip, cracked battery tube threads cracked case from display window corner and stained end cap sticker.The test infusion set and reservoir does lock into place.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 11100376
• MDR Text Key: 225784924
• Report Number: 2032227-2020-222819
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000643169507241
• UDI-Public: (01)000000643169507241
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: B5723NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 113