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 No Display/Image (1183); Loss of Data (2903); Key or Button Unresponsive/not Working (4063)

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

Event Date 03/04/2024

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 on the pump error 68 alarm and pump blank display.It was also reported on pump keypad anomaly.Troubleshooting was performed and the pump display was blank at the time of trouble shoot.No harm requiring medical intervention was reported.The customer will discontinue use of the pump and revert to backup plan as per the health care professional instructions and a serialized device will be replaced.The insulin pump will be returned for failure analysis.

Manufacturer Narrative

The pump passed the displacement test, active current test and self test.No blank display, pump error 68 alarm or stuck button error alarm noted during testing.However, high sleep current found during testing.Successfully downloaded history files and traces using thus.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.Stuck button error alarm found in the pump history file/trace on (b)(6) 2024 at 17:37:03.Pump error 68 alarm found in the pump history file/trace on (b)(6) 2024 at 19:14:14.Failed battery test alarm found in the pump history file/trace on (b)(6) 2024 at 17:38:32.Pump was cut open to perform visual inspection and found moisture damage on the keypad flex connector, pcba 1, pcba 2, force sensor, harness assembly vibrator and corroded battery tube.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: corroded battery tube, cracked select button keypad overlay, minor scratched lcd window, scratched case and pillowing keypad overlay.Blank display not confirmed.High sleep current due to moisture damage electronic assembly, harness assembly vibrator and corroded battery tube.Moisture damage found on the keypad flex connector, pcba 1, pcba 2, force sensor, harness assembly vibrator and corroded battery tube.Keypad/button unresponsive/button error alarm was confirmed due to moisture damage on keypad flex connector.Failed battery test alarm due to moisture damage electronic assembly, harness assembly vibrator and corroded battery tube.Pump error 68 alarm due to moisture damage electronic assembly, harness assembly vibrator and corroded battery tube.Cosmetic damage found on the pump case.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
• 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: 18928145
• MDR Text Key: 338071576
• Report Number: 2032227-2024-144604
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317157
• UDI-Public: (01)000000763000317157
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,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-1712K
• Device Catalogue Number: MMT-1712K
• Device Lot Number: HG5UWMQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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