MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1760KPK 670G PATHWAY BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1760KPK
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a broken force sensor was detected during seating or regular delivery and critical pump error alarm.Customer stated buttons don't work, it asked to be rewound and got a critical pump error.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with critical pump error due to moisture damage to force sensor.Device received with corroded electronic assemblies and corroded motor home switch therefore, unable to download and verify pump error 35.Device unable to perform displacement test, rewind, prime or seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement, and self test or verify keypad unresponsive or button error alarm due to critical pump error (open book image) alarm.

• Brand Name: KIT MMT-1760KPK 670G PATHWAY BLACK MG
• 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
• MDR Report Key: 10187895
• Report Number: 2032227-2020-135881
• Device Sequence Number: 3017377
• Product Code: OZP
• UDI-Device Identifier: 00763000283445
• UDI-Public: (01)00763000283445
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/07/2020

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-1760KPK
• Device Catalogue Number: MMT-1760KPK
• Device Lot Number: HG411MF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1