MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MG/DL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1812

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

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

Event Date 03/01/2024

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, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Information received by medtronic indicated that the customer reported that the pump was blank and black, unable to turn it back on, and exposed to moisture.Troubleshooting was performed and the customer stated that the contacts on the battery cap were neither missing nor damaged and the spring was neither damaged nor corroded.It was advised to insert a new aa battery; however, the display was not returned after the pump restart.No harm requiring medical intervention was reported.The customer discontinued using the pump and it will be returned for product analysis.

Manufacturer Narrative

The pump passed the displacement test and self-test.No blank display noted during testing.Pump passed the leak test.However, unit received with unexpected battery power loss and had high sleep and active currents.Successfully downloaded history files and traces using thump.Pump was cut open to perform visual inspection and moisture damage on the [pcba 1, j7 connector / pcba 2].The sc1 cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: scratched case.Alleged blank display was not observed during analysis and passed all required testing.Blank display not confirmed.However, unexpected battery power loss confirmed during testing due to severe moisture damage on the [pcba 1, j7 connector / pcba 2].Moisture exposure confirmed on the [pcba 1, j7 connector / pcba 2].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: MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MG/DL
• 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: 18901542
• MDR Text Key: 337623793
• Report Number: 2032227-2024-142477
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000769468
• UDI-Public: (01)000000763000769468(17)261102
• 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: 05/15/2024

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-1812
• Device Catalogue Number: MMT-1812
• Device Lot Number: NG3650805H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2023
• 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