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 Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

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 possible over delivery with the insulin pump.It was reported that the customer had experienced hypoglycemia and had treated it with carbohydrate intake.Troubleshooting was performed, and the high pressure test failed on the insulin pump.No harm requiring medical intervention was reported.The customer will discontinue the use of the insulin pump and will be returned for analysis.

Manufacturer Narrative

The pump passed all functional testing including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test, and the dat test at.08735 inches.Successfully downloaded the trace and history files using thus and carelink upload was successful.No over-delivery anomaly was noted during testing.The pump was cut open to perform a visual inspection.No evidence of physical or moisture damage was found on the electronic assembly (pcba 1 and pcba 2), motor, or force sensor.A test p-cap does lock into place inside the reservoir compartment properly.The following were noted during the physical inspection: scratched case and pillowing keypad overlay.The pump passed all functional testing.Over-delivery and low bg anomalies are not confirmed.The pump history file lists six (6) boluses on the event date, (b)(6) 2023.(b)(6) 2023 10:44:29.000 dualboluspartdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 0.95 squarebolusamountprogrammed = 0.95 bolusamountdelivered = 0.95 dualboluspart = normal part of a dual bolus (b)(6) /2023 12:14:00.000 dualboluspartdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 0.95 squarebolusamountprogrammed = 0.95 bolusamountdelivered = 0.95 dualboluspart = square part of a dual bolus (b)(6) 2023 14:48:52.000 dualboluspartdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 1.325 squarebolusamountprogrammed = 1.3 bolusamountdelivered = 1.325 dualboluspart = normal part of a dual bolus (b)(6) 2023 15:04:33.000 dualboluspartdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 1.325 squarebolusamountprogrammed = 1.3 bolusamountdelivered = 0.175 dualboluspart = square part of a dual bolus (b)(6) 2023 19:52:03.000 dualboluspartdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 1.15 squarebolusamountprogrammed = 1.15 bolusamountdelivered = 1.15 dualboluspart = normal part of a dual bolus (b)(6) 2023 20:22:00.000 dualboluspartdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 1.15 squarebolusamountprogrammed = 1.15 bolusamountdelivered = 1.15 dualboluspart = square part of a dual bolus please see below for the daily total of all insulin delivered on the event date, (b)(6) 2023: (b)(6) 2023 00:00:00.000 dailytotals dailytotalofallinsulindelivered = 18.925 dailytotalofbasalinsulindelivered = 13.225 dailytotalofbolusinsulindelivered = 5.7 there were no auto suspend events on the event date, 10/9/2023.Please see below for the user suspend event on the event date, (b)(6) 2023: (b)(6) 2023 15:10:22.000 insulindeliverystopped eventtype = 30 reasonforinsulindeliverysuspension = user suspended 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.

• 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
• 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: 18038714
• MDR Text Key: 326962814
• Report Number: 2032227-2023-294301
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317195
• UDI-Public: (01)000000763000317195(17)250825
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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: NG3156392H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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
• Patient Age: 7 YR