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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The insulin pump involved in this event is the ngp 640 insulin pump which is not marketed in the united states.However, the device is similar to the ngp insulin pump, which is marketed in 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 the pump was over-delivering.Troubleshooting was performed and found that the pump was giving more insulin than programmed and this issue reoccurs.No harm requiring medical intervention was reported.The customer will discontinue using the insulin pump.The insulin pump will be returned for analysis.

Manufacturer Narrative

The pump passed the functional tests, 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 dat at 0.08755 inches.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.In further full review of the pump history/traces on the event date of 17-feb-2023, there is no unexpected alarms/suspends.Please see below for the daily total of basal/bolus and all insulin delivered on the event date 17-feb-2023 listed on smartsolve.Dailytotalofallinsulindelivered = 10.25.Dailytotalofbasalinsulindelivered = 3.4.Dailytotalofbolusinsulindelivered = 6.85.02/17/2023 05:58:14.000 normalbolusdelivered, bolusprogrammingmethod = bolus wizard, normalbolusamountprogrammed = 1.85, bolusamountdelivered = 1.85.02/17/2023 05:58:48.000 normalbolusdelivered, bolusprogrammingmethod = bolus wizard, normalbolusamountprogrammed = 0.3, bolusamountdelivered = 0.3.02/17/2023 10:01:28.000 normalbolusdelivered, bolusprogrammingmethod = bolus wizard, normalbolusamountprogrammed = 1.4, bolusamountdelivered = 1.4.02/17/2023 10:52:57.000 normalbolusdelivered, bolusprogrammingmethod = bolus wizard, normalbolusamountprogrammed = 1.5, bolusamountdelivered = 1.5.02/17/2023 12:31:38.000 normalbolusdelivered, bolusprogrammingmethod = bolus wizard, normalbolusamountprogrammed = 1.8, bolusamountdelivered = 1.8.There was no bolus/basal of 80u delivery in the formatted history file noted.The pump was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts (at quick bolus speed) and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.Please see below for pump errors/alarms noted 1 week prior to the event date 17-feb-2023 in the formatted history file.  insert battery alarm was recorded and found in the formatted history file on: 02/14/2023 17:40:30.000, 02/17/2023 16:08:00.000, 02/17/2023 18:03:07.000.Power management graph was successfully generated.The power management tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.No alarms/alerts were noted.No power error 25, low battery alert, power loss alarm and replace battery alert/replace battery now alarm noted 1 week prior to the event date 17-feb-2023 in the formatted history file.  insert battery alarm was expected since the battery was removed from the pump.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: a stained keypad overlay, a scratched case and a serial number label fading.The pump passed all the required testing.Customer alleged for possible over delivery was not confirmed.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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 16511291
• MDR Text Key: 310981951
• Report Number: 2032227-2023-168274
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317195
• UDI-Public: (01)000000763000317195
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• 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: HG5V4R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1