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
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional 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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Information received by medtronic indicated that the insulin pump's bottom buttons were harder to push.Customer reported that the insulin pump received no delivery alarms and motor error alarm.Customer reported that they did not wear insulin pump because either it have too much of insulin or gave too little insulin.Insulin pump also had scratches on screen.Customer declined to troubleshooting with 24 hours helpline.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to flattened (escape and act ) button dome switch (no crease) and partial unlocked j2/lcd keypad connector noted during visual inspect.Unable to perform all functional testing including the displacement, operating currents, a21 error test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test or verify under delivery anomaly, failed battery test alarm, no delivery alarm, charge battery anomaly, over delivery and motor error alarm due to buttons not responding.Device received with cracked battery tube threads, cracked lcd window, cracked reservoir tube lip and cracked case display window corner.The p-cap locks into the reservoir compartment properly noted.Motor passed motor test.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• 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
• MDR Report Key: 10372233
• Report Number: 2032227-2020-158823
• Device Sequence Number: 19430951
• Product Code: OYC
• UDI-Device Identifier: 00643169507241
• UDI-Public: (01)00643169507241
• 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,Followup
• Report Date (Section B): 04/29/2021

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-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: B5723NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR