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

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 11/21/2022

Event Type  Injury  

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 640g 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 experienced hypoglycemia with blood glucose value above 400 mg/dl and reported possible under delivery of insulin.The current blood glucose value also above 400 mg/dl.Troubleshooting was performed.Customer received occlusion alarms after the set was placed in lipomas.Customer was hospitalized to treat hyperglycemia.Customer tested positive for ketones.The pump was used within the 48 hours of the reported event and the smart guard/auto mode was not active at the time of event.No harm requiring medical intervention was reported.The customer will continue the use of the insulin pump and will not be returned for analysis.

Manufacturer Narrative

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

Updated summary: customer had hyperglycemia, not hypoglycemia.Pump was used at the time of the incident.Pump does not have smartguard/auto mode feature.There was harm requiring medical intervention - customer was hospitalized.On (b)(6) 2022, the customer's healthcare provider (nurse) called to report customer had been hospitalized for diabetic ketoacidosis at 14:15 that day.Caller reported customer's blood glucose upon admission was more than 400mg/dl and customer was positive for ketones.Caller reported customer had changed infusion set/reservoir and performed boluses to decreased blood glucose, but it was not effective.Caller reported customer changes infusion set/reservoir every 2-3 days as per instruction for use.Caller also reported customer continued to receive high blood glucose alerts and occlusion alarms.Caller reported customer was wearing insulin pump at time of hospitalization and asked if the insulin pump needed to be replaced.Caller and customer performed troubleshooting with 24-hour technical support and it was discovered customer had inserted infusion set into a lipoma, per caller, and insulin was not absorbed.The 24-hour technical support team member also performed 5 unit cannula fill test, displacement verification test, and self-test with caller and customer.The insulin pump passed all of these tests.

• 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: 15969708
• MDR Text Key: 305356009
• Report Number: 2032227-2022-376735
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000367046
• UDI-Public: (01)000000763000367046
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712KL
• Device Catalogue Number: MMT-1712KL
• Device Lot Number: HG4SUHD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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
• Treatment: FRN-UNK-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization