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

Model Number	MMT-723NAS
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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/a33 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.Unit received with normal operating current.No unexpected low battery alarm anomalies noted.No unexpected failed battery alarm anomalies noted.No unexpected reset alarm noted.Insulin pump received with scratched reservoir tube window and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.(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 had rewinds and reprimes issues.Customer stated that the insulin pump had no delivery alert and also rejected new battery and surface scratches on reservoir window and screen.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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: 10492616
• Report Number: 2032227-2020-172175
• Device Sequence Number: 16742196
• Product Code: OYC
• UDI-Device Identifier: 00643169202399
• UDI-Public: (01)00643169202399
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/04/2020

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-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: B1723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR