MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712K

Device Problems Break (1069); No Display/Image (1183); Moisture or Humidity Problem (2986)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

It was reported to medtronic minimed that the customer experienced physical crack on pump and exposed to water.The customer reported no adverse event.The event involved product(s) mmt-1712k.Troubleshooting was performed and insulin pump will be replaced.No harm requiring medical intervention was reported.Product return was requested.

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.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.Pump received with flashing medtronic logo.Unable to perform the displacement test and self-test due to flashing medtronic logo.Unable to download history files and traces using thus due to flashing medtronic logo.Pump was cut open to perform visual inspection and found moisture damage on the pcba 1, pcba 2, force sensor, motor, corroded battery tube, and harness assembly vibrator.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: scratched case, cracked keypad overlay, cracked case (battery tube), pillowing keypad overlay, corroded battery tube, and corroded home switch.Flashing medtronic logo was confirmed during analysis due to moisture damage on the electronic assemblies.Pump failed to download history files and traces due to medtronic logo flashing screen.Confirmed cosmetic damage to the battery compartment.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.

• Brand Name: 640G INSULIN PUMP MMT-1712K
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 19049022
• MDR Text Key: 339565673
• Report Number: 2032227-2024-151372
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317140
• UDI-Public: (01)000000763000317140
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712K
• Device Catalogue Number: MMT-1712K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1