MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problem Device Alarm System (1012)

Patient Problems Hyperglycemia (1905); Seizures (2063)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that the customer called and reported that they received emergency medical assistance on (b)(6) 2019 with blood glucose levels of 360 mg/dl at the time of the incident.The customer did not mention how they treated.The customer did not mention any high symptoms.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed as the customer declined.The customer was in the emergency room on (b)(6) 2019 with high blood glucose and diabetic ketoacidosis after the pump did not alert them that they were low on insulin and that their pump battery was low.On (b)(6) 2019 the customer was admitted with a blood glucose of 580 mg/dl.The customer had many lows including one with a seizure.The customer also mentioned sensor glucose versus blood glucose differences.The insulin pump will not be returned for analysis.

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.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.The information has been updated and provided in b5 section of this report.

Event Description

There was no november 20, 2019 incident.On (b)(6) 2019, customer was admitted with a blood glucose of 580 mg/dl for (b)(4) and on (b)(6) 2019, the customer went to emergency room visit with a blood glucose of 360 mg/dl for this case.Customer did not have any lows with seizure, her husband was the one that had lows with a seizure.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 9584587
• MDR Text Key: 174891539
• Report Number: 3004209178-2020-54992
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840(17)180826
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2018
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2C8NV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRN-MMT-332-RSVRUNOMED SET; FRN-MMT-332-RSVRUNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Weight: 115