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

Model Number	MMT-723NAL
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
The customer reported via phone call that they received no delivery alarm, a motor error, battery issues, and had scratches on the screen.The customer's blood glucose was unknown at the time of incident.Troubleshooting was not provided.No alarms were cleared.No other information was provided.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with minor scratched on lcd display window noted.The test reservoir p-cap was able to lock in place.Device passed self test, off no power test and all operating currents tested within the specific range.No failed battery test were noted.Unable to prime during prime/a33 test due to faulty forces sensor resistor.Device passed basic occlusion and displacement test.Unable to confirm motor error alarm due to prime anomaly.The motor was tested outside of the device and passed.(b)(4).
Additional Manufacturer Narrative
Device received with minor scratched on lcd display window noted.The test reservoir p-cap was able to lock in place.Device passed self test, off no power test and all operating currents tested within the specific range.No failed battery test were noted.Unable to prime during prime or a33 test due to faulty force sensor resistor.Device passed basic occlusion and displacement test.Unable to confirm motor error alarm due to prime anomaly.The motor was tested outside of the device and passed.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 9892659
• Report Number: 3004209178-2020-91382
• Device Sequence Number: 11367760
• Product Code: OYC
• UDI-Device Identifier: 00613994743916
• UDI-Public: (01)00613994743916
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 06/16/2020

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-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: A2723NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 05/29/2020
• Initial Report FDA Received Date: 03/28/2020
• Supplement Report FDA Received Date: 06/01/2020; 06/16/2020
• 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: 183