MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755K PUMP 630G 3ML BK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-1755K
Medical Device Problem Codes	Material Integrity Problem (2978); Moisture or Humidity Problem (2986); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with critical pump error due to moisture damage to force sensor.Unit received with corroded electronic assemblies and corroded motor home switch.The pump was received with a loose metal contact on the battery cap due to a broken three heat stake post.A test battery cap locks securely into place and the pump powered up properly.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had critical pump error.Customer reported they received the open book image on the insulin pump screen.Customer stated no insulin pump error displayed on the screen before the open book image.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: KIT MMT-1755K PUMP 630G 3ML BK MG
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 9970732
• Report Number: 2032227-2020-104943
• Device Sequence Number: 11461701
• Product Code: OZO
• UDI-Device Identifier: 00643169752726
• UDI-Public: (01)00643169752726
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2020

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-1755K
• Device Catalogue Number: MMT-1755K
• Device Lot Number: HG1HFKD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1