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

Model Number	MMT-1780KL
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After battery installation, an "insert a new aa battery" message immediately appeared.After further review, did not note any evidence of previous moisture presence or corrosion on any of the electronic boards, assemblies, or the motor inside the unit.After taking the boards out of the case and installing them into another known good case, the error message appeared again.After swapping a known good pcba2 onto pcba1 and putting them back into the known good case, the error message finally disappeared.The problem seems to be isolated to pcba2.Unable to perform the displacement, sleep current measurement, active current measurement, and self tests due to the recurring error message.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had failed battery test alert.No harm requiring medical intervention was reported.The insulin pump was returned for analysis.

• Brand Name: 670G INSULIN PUMP MMT-1780KL
• 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: 10458114
• Report Number: 2032227-2020-168776
• Device Sequence Number: 3218444
• Product Code: OZP
• UDI-Device Identifier: 00763000365882
• UDI-Public: (01)00763000365882(17)230701
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/26/2020

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 Expiration Date: 07/01/2023
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG4FD6H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 125