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

Model Number	MMT-1780KL
Medical Device Problem Codes	Break (1069); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been added which was not included with the initial report.The information has been provided in section h7 and h9 with this follow up report.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Select patient information cannot be provided due to regional privacy regulations.Pump received with blank flashing white display.Unable to perform the displacement test, sleep current test, active current test and self test due to blank flashing white display.Unable to download history files and traces using thus due to blank flashing white display.Using a test pcba 1 and the original pcba 2, the pump was stuck on partial display anomaly.Using a test pcba 2 and the original pcba 1, the pump had blank flashing white display.Blank flashing white display and blank display due to corroded electronic assembly.Pump was cut open to perform visual inspection and found corroded electronic assembly, force sensor, motor, and battery tube.The j6 connector was broken off from pbca1.Test p-cap and reservoir locked properly into reservoir compartment during testing.No cracked lcd controller (pcba 1) or cracked lcd glass noted.The pump was received with cracked battery tube threads, and cracked case at corner of the belt clip rail, the following were noted during visual inspection: minor scratched display window, scratched display window cover, scratched case, and pillowing keypad overlay.Blank flashing white display was confirmed during analysis due to corroded pcba 1.Partial display anomaly was confirmed during analysis due to corroded pcba 2.Cosmetic damage was confirmed at back of the pump.Unable to download confirmed.Exposed to moisture confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information received by medtronic indicated that the customer reported that there is a crack at the back of the pump on the battery compartment area and it was reported that customer went swimming not knowing that there is a crack now the pump won¿t turn on.No harm requiring medical intervention was reported.Troubleshooting was performed.The customer discontinued using the product and pump was returned for product analysis.

• Brand Name: 670G INSULIN PUMP MMT-1780KL
• Common Device Name: AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 20276075
• Report Number: 2032227-2024-242043
• Device Sequence Number: 7315709
• Product Code: OZP
• UDI-Device Identifier: 00763000283513
• UDI-Public: (01)00763000283513(17)230226
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 02/26/2023
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG44X4Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/22/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2032227-07-23-2024-001-C
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female