MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 670G INSULIN PUMP MMT-1780KP; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1780KP
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with no response form any button, problem isolated to keypad assembly.Unit received with j1 connector at pcba1 properly connected.No damage or moisture damage on keypad assembly noted.Unable to perform self test or displacement test due to keypad anomaly.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the center button was unresponsive and that if press it to go to the main menu he has to press it 9 times.Customer states that numbers were not ramping on their own.Customer states the scroll bar was moving with no input.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: 670G INSULIN PUMP MMT-1780KP
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 10274865
• Report Number: 2032227-2020-146723
• Device Sequence Number: 16775696
• Product Code: OZP
• UDI-Device Identifier: 00763000173043
• UDI-Public: (01)00763000173043
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 07/15/2020

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-1780KP
• Device Catalogue Number: MMT-1780KP
• Device Lot Number: HG3FUAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR