MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAP
Medical Device Problem Codes	Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit was received with normal operating currents and passed self-test, a21 error test.No unexpected low battery, battery out limit or failed battery test alarms noted during testing.However, a test reservoir was installed and did not lock in place due to completely broken reservoir tube lip.Unable to perform the displacement test due to completely broken reservoir tube lip.Unit had missing reservoir tube o-ring, broken battery tube threads.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the there is damage to the pump and the plastic was chipping away from the top of the reservoir and battery compartment.Reservoir was able to lock in place when inserted into the insulin pump.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-523RNAP
• 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: 10013443
• Report Number: 2032227-2020-112002
• Device Sequence Number: 2208634
• Product Code: OYC
• UDI-Device Identifier: 00643169513082
• UDI-Public: (01)00643169513082
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/30/2020

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A1523RNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 64