MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MINIMED 720G OUS BLE CONNECT 3.0 MGDL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1810

Device Problem No Display/Image (1183)

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

Event Date 03/08/2024

Event Type  malfunction  

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.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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.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 Description

Information received by medtronic indicated that the customer reported blank display.Troubleshooting was performed and found that there was no damage to the battery cap or the battery cap contacts.The pump display did not return after inserting a new battery and restarting.The issue was not resolved.No harm requiring medical intervention was reported.The customer will discontinue the use of the device and revert to the backup plan as per health care professional instructions.The pump will be returned for analysis.

Manufacturer Narrative

Inserted a test sc1-cap into the retainer ring, and it locked in place properly.The retainer ring is solidly attached to the reservoir tube lip.Did not note any cracks in or around the reservoir tube lip, or in the retainer ring.Did not note any cracks in the battery tube or in the battery threads.The pump was received without a battery cap.The pump passed the leak test.The pump was received with a blank display.Unable to perform the displacement, sleep current measurement, active current measurement, and self tests due to the blank display.The case was cut open.After visual inspection, did not note any signs of previous moisture presence or corrosion inside the battery compartment or on any of the boards, assemblies, and the motor inside the pump.There are cracks within the lcd screen and on the circuitry around the lcd controller however.Pcba2 was plugged into a known good pcba1, and in this configuration, the pump was able to boot up.The software version was then able to be obtained.In summary, the customer¿s report of a blank display was confirmed during testing.This is due to the cracks within the lcd screen and on the circuitry around the lcd controller.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MINIMED 720G OUS BLE CONNECT 3.0 MGDL
• 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
• 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: 18926496
• MDR Text Key: 337928882
• Report Number: 2032227-2024-144351
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000769420
• UDI-Public: (01)000000763000769420(17)261204
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 05/27/2024

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-1810
• Device Catalogue Number: MMT-1810
• Device Lot Number: NG3674797H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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
• Patient Age: 15 YR