MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAL
Medical Device Problem Codes	Mechanical Problem (1384); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump passed the displacement test.Unit received with compromised force sensor system alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform prime/compromised force sensor system test, excessive no delivery test and occlusion test or verify prime/fill due to compromised force sensor system alarm.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the customer had issue during the prime or rewound of insulin pump.Customer stated they are unable to exit the preparing to prime loop.Customer stated they did not receive 2nd series of beeps nor did numbers appear on the screen.No harm requiring medical intervention was reported.The device will be return for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL
• 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: 10336422
• Report Number: 2032227-2020-153833
• Device Sequence Number: 2912587
• Product Code: OYC
• UDI-Device Identifier: 00613994402035
• UDI-Public: (01)00613994402035
• Combination Product (Y/N): N
• 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): 07/28/2020

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-722NAL
• Device Catalogue Number: MMT-722NAL
• Device Lot Number: A5722NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 98