MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1712KL 640G V4.10 BK SF MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712KL

Device Problems No Display/Image (1183); Power Problem (3010)

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

Event Date 03/27/2024

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.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.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.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

It was reported to medtronic minimed that the customer experienced blank display, unexpected battery power loss.The customer reported no adverse event.The event involved product(s) mmt-1712kl.Troubleshooting was not performed.No harm requiring medical intervention was reported.It was unknown whether the customer will continue the use of the device.Mmt-1712kl was requested and customer response was the device will be returned.

Manufacturer Narrative

Unit received with blank display.After multiple new batteries and battery caps unit remained on blank display.Unable to perform the displacement test, sleep current test, active current test and self test due to blank display.Unable to download history files and traces using thus software due to blank display.Test p-cap and reservoir locked properly into reservoir compartment during testing.Pump was cut open to perform visual inspection of connectors and electronic assemblies.No physical evidence or moisture damage on the electronic assembly, motor, or force sensor was found.Swapping out test boards to pinpoint the faulty board.Swapping out test boards confirms blank display.Isolated to pcba 2.Physical damage noted during visual inspection: scratched case, keypad overlay texture damage and label damage (faded and stained).In conclusion, customer concern for blank display was confirmed due to pcba2.Problem isolated to pcba 2.Unable to download due to blank display.Unable to confirm unexpected battery power loss.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: PUMP MMT-1712KL 640G V4.10 BK SF MG
• 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: 19150537
• MDR Text Key: 340707884
• Report Number: 2032227-2024-154845
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317195
• UDI-Public: (01)000000763000317195
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/22/2024

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-1712KL
• Device Catalogue Number: MMT-1712KL
• Device Lot Number: HG6E38Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 08/03/2022
• 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