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); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
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 had act button was harder to push.The customer also stated that the insulin pump had lost settings when changing out batteries, rewind was slower, the pump had no delivery alarm.The customer also stated that the battery cap had crack around it.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with all buttons responding properly.No damage on keypad assembly.No unlocked j2/lcd keypad connector.Device passed the displacement test, self test rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test.No unexpected rewind anomalies noted.No excessive no delivery/occlusion alarm noted.Device received with cracked battery tube threads and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.(b)(4).

• 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
• MDR Report Key: 10157216
• Report Number: 2032227-2020-131533
• Device Sequence Number: 11629994
• Product Code: OYC
• UDI-Device Identifier: 00643169446472
• UDI-Public: (01)00643169446472
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/20/2020

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: B3723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 190