MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711K

Device Problems Excess Flow or Over-Infusion (1311); Communication or Transmission Problem (2896)

Patient Problem Hypoglycemia (1912)

Event Date 01/14/2023

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 640g insulin infusion 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 not working and was unable to upload to carelink and experienced hypoglycemia and was treated with food.  troubleshooting was performed and found that the customer had been using the insulin pump system within 48 hours.It was also found that the auto mode feature was not active at the time of the event.No further patient complications were 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.08640 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 programmed with a test guardian 2 link transmitter and a glucose sensor simulator.The display showed the calibrate your sensor alarm properly after completion of the warmup.The pump calibrated to the programmed test value (7.5 mmol/l) properly and displayed correctly on the display graph.Programmed the sensor low settings for 5.0 mmol/l and turned the alert before low, alert on low, suspend on low, and resume basal alerts on.The pump was monitored, the glucose sensor simulator bg level was lowered, and the alert before low activated at 6.4 mmol/l, the alert on low activated at 4.9 mmol/l, the suspend on low activated at 4.9 mmol/l, and the resume basal delivery functioned properly.No suspend before low, alert on low, suspend on low, or resume delivery anomalies were noted.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, cracked select button keypad overlay, stained keypad overlay, and pillowing keypad overlay.The pump passed all functional testing.Over-delivery and low bg anomalies are not confirmed.Suspend before low, alert on low, suspend on low, and resume delivery anomalies are not confirmed.Please see below for the following programmed bolus deliveries for the event date (1/14/2023) and reporting date (1/15/2023): 01/14/2023 07:25:52 normalbolusdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 4.7 bolusamountdelivered = 4.7 01/14/2023 12:00:38 normalbolusdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 3 bolusamountdelivered = 3 01/14/2023 18:07:46 normalbolusdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 3.3 bolusamountdelivered = 3.3 01/15/2023 03:48:11 normalbolusdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 1 bolusamountdelivered = 1 01/15/2023 07:37:06 normalbolusdelivered bolusprogrammingmethod = bolus wizard normalbolusamountprogrammed = 4.7 bolusamountdelivered = 4.7 01/15/2023 08:26:18 normalbolusdelivered bolusprogrammingmethod = manual bolus normalbolusamountprogrammed = 1.4 bolusamountdelivered = 1.4 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: 640G INSULIN PUMP MMT-1711K
• 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: 16252415
• MDR Text Key: 308357957
• Report Number: 2032227-2023-137500
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317089
• UDI-Public: (01)000000763000317089
• Combination Product (y/n): N
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Device Lot Number: HG53CTH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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