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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin pump was received with blank display due to corroded battery tube.Unable to perform operating currents, self-test, unexpected restart error test and displacement test due to blank display.The insulin pump had cracked reservoir tube lip, cracked reservoir tube window and cracked case at reservoir tube window corners.The reservoir tube lip was tested with the test reservoir locked in place properly and no anomaly noted.
Event or Problem Description
Information received by medtronic indicated that the insulin pump fell out and after this the piston was not working properly and insulin pump was cracked.No harm requiring medical intervention was reported.The device was returned 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: 9953721
• Report Number: 3004209178-2020-98633
• Device Sequence Number: 11371924
• Product Code: OYC
• UDI-Device Identifier: 00613994622570
• UDI-Public: (01)00613994622570
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

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: A7722NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1