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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 09/23/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).Deceased event details.Date of customer passing: (b)(6) 2021.Date the pump was last worn: monday (b)(6) 2021.Insulin pump had minor scratched display window, scratched case, cracked battery tube threads, scratched/torn serial number label, stained keypad overlay, pillowing keypad overlay, cracked keypad overlay at the select button and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thus and care link upload was successful.Insulin pump passed the functional test, 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 0.0873 inches.Insulin pump did not have a battery installed when received.Insulin pump passed the functional testing.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

It was reported via phone call that the customer passed away in hospital on (b)(6) 2021.The customer was hospitalized on (b)(6) 2021 due to heart issues, kidney problem.The cause of death was heart attack.The customer was not wearing the insulin pump at the time of death.The insulin pump had been disconnected on (b)(6) 2021.The caller agreed to return the insulin pump for analysis.The case was reported on basis of failure analysis.

Manufacturer Narrative

Retainer ring = clear.On (b)(6) 2021, the insulin pump was returned due to patient passing away, but not alleging device.Device had minor scratched display window, scratched case, cracked battery tube threads, scratched/torn serial number label, stained keypad overlay, pillowing keypad overlay, cracked keypad overlay at the select button and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thus and carelink upload was successful.Device passed the functional test, 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 delivery accuracy test at 0.0873 inches.The device did not have a battery installed when received.Please see below for the customer's daily total of all insulin delivered surrounding the days prior to the event date.There was no data listed on the event date (b)(6) 2021 listed on smartsolve.The formatted history file lists data from (b)(6) 2019 to (b)(6) 2021.On (b)(6) 2021 dailytotalofallinsulindelivered = 20.175.On (b)(6) 2021 dailytotalofallinsulindelivered = 28.75.On (b)(6) 2021 dailytotalofallinsulindelivered = 32.On (b)(6) 2021 dailytotalofallinsulindelivered = 20.On (b)(6) 2021 dailytotalofallinsulindelivered = 9.725.On (b)(6) 2021 dailytotalofallinsulindelivered = 0.On (b)(6) 2021 dailytotalofallinsulindelivered = 0.In summary, pump passed all required testing.Device was not returned for an allegation.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.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0958-2020.(b)(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: 12844911
• MDR Text Key: 287322662
• Report Number: 2032227-2021-220442
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000192136
• UDI-Public: (01)000000763000192136
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0958-2020
• Patient Sequence Number: 1