MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 620G INSULIN PUMP MMT-1710K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1710K

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

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

Event Date 12/09/2022

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.The insulin pump involved in this event is the ngp 620g 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 multiple insulin flow-blocked alarms.The customer had reported a blood glucose value of 100 mg/dl which was treated by manual injections.No further details were provided.No additional consequences requiring medical intervention were reported.Troubleshooting was performed and advised the customer to change the quick set and reservoir.It is unknown if the customer had continued using the device.The insulin pump will not be returned for product analysis.

Manufacturer Narrative

S/w version 4.11b retainer ring = black pump case: ngp customer returned pump for alleged possible under delivery and insulin flow blocked alarm observed on 09-dec-2022.Unit passed the self test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, and dat at.0868 inches.Test p-cap and reservoir locked properly into reservoir compartment during testing.No unexpected insulin flow blocked alarms noted during testing.Successfully utilized thus and carelink to download history/trace files.Verified the pump alarmed no delivery during basal/bolus/priming in pump downloaded history near event date 27 times.Listed below are the dates/times of no delivery alarms listed on or near event date along with during basal/bolus/priming: 4 no delivery alarm during basal: start date 12/06/2022 10:21:00.000 end date 12/06/2022 21:26:00.000 2 no delivery alarm during bolus: start date 12/06/2022 21:27:45.000 end date 12/08/2022 19:40:21.000 1 no delivery alarm during basal: start date 12/08/2022 19:50:00.000 2 no delivery alarm during bolus: start date 12/08/2022 20:02:03.000 end date 12/08/2022 20:02:21.000 1 no delivery alarm during priming: start date 12/08/2022 20:03:21.000 3 no delivery alarm during basal: start date 12/08/2022 22:26:00.000 end date 12/08/2022 23:53:00.000 1 no delivery alarm during priming: start date 12/08/2022 23:54:46.000 2 no delivery alarm during basal: start date 12/09/2022 14:20:00.000 end date 12/09/2022 14:22:00.000 9 no delivery alarm during priming: start date 12/09/2022 14:24:52.000 end date 12/09/2022 14:54:43.000 1 no delivery alarm during bolus: start date 12/09/2022 14:59:53.000 1 no delivery alarm during basal: start date 12/09/2022 15:09:00.000 the daily total of all boluses on 09-dec-2022 is 5.6 u.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, or force sensor.The following were noted during visual inspection: stained keypad overlay, pillowing keypad overlay.Pump passed function testing.No unexpected insulin flow blocked alarms noted during testing.No delivery alarm not confirmed.No evidence of under delivery anomaly noted during analysis, possible under delivery anomaly 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: 620G INSULIN PUMP MMT-1710K
• 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: 16047555
• MDR Text Key: 308247886
• Report Number: 2032227-2022-387547
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1710K
• Device Catalogue Number: MMT-1710K
• Device Lot Number: HG4NTBY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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