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

Model Number	MMT-1780KPK
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Loss of Data (2903)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit passed selftest however, unit received pump error 38 during rewind due to corroded motor home switch.Unable to perform displacement test, prime/seating test, basic occlusion test, force sensor test, and occlusion test or verify pump error 68, pump error 49, and pump error 23 due to pump error 38.Unit received with corroded electronic assemblies and corroded battery tube.
Event or Problem Description
Information received by medtronic indicated that the insulin pump received pump error.Customer was able to clear alarm and rewind process.Customer stated that insulin pump experienced unexpected restart.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: PUMP MMT-1780KPK 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; * 00777-3869
• MDR Report Key: 10673117
• Report Number: 2032227-2020-190284
• Device Sequence Number: 2744273
• Product Code: OZP
• UDI-Device Identifier: 00763000096984
• UDI-Public: (01)00763000096984
• 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
• Report Date (Section B): 10/13/2020

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-1780KPK
• Device Catalogue Number: MMT-1780KPK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1