MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

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

Patient Problem Myocardial Infarction (1969)

Event Date 06/11/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).Date of customer passing: (b)(6) 2021.Insulin pump had detached retainer, broken reservoir tube lip, minor scratched display window, scratched case, pillowing keypad overlay and cracked keypad overlay at the select button.Insulin pump passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test and force sensor test.The test p-cap and reservoir will not lock in place in the reservoir compartment due to a completely detached retainer.History download was successful using thus and carelink upload was successful.Unable to complete the functional testing or perform the displacement test, occlusion test and dat test due to a completely detached retainer.Insulin pump did not have a battery installed when received.Unable to complete the functional testing or perform the displacement test, occlusion test and dat test due to a completely detached retainer.

Event Description

It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2021 due to massive heart attack.The cause of death was massive heart attack.The caller stated it was sudden death.The customer¿s blood glucose was unknown mg/dl at the time of death.The customer was not wearing the insulin pump at the time of death.The insulin pump had been disconnected 58 days prior to passing.The insulin pump return for analysis.The case was reported on the basis of fa.

Event Description

It was reported that the customer passed on (b)(6) 2021 in the hospital but had a massive heart attack on (b)(6) 2021.Customer was admitted to the hospital on (b)(6) 2021 due to the massive heart attack.

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

Manufacturer Narrative

Retainer ring = clear (completely detached retainer).Date of customer passing: (b)(6) 2021.Device was returned with no allegations.The insulin pump had detached retainer, broken reservoir tube lip, minor scratched display window, scratched case, pillowing keypad overlay and cracked keypad overlay at the select button.The insulin pump passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test and force sensor test.The test p-cap and reservoir will not lock in place in the reservoir compartment due to a completely detached retainer.History download was successful using thus and carelink upload was successful.Unable to complete the functional testing or perform the displacement test, occlusion test and delivery accuracy test due to a completely detached retainer.The insulin pump did not have a battery installed when received.Please see below for the date range listed in the formatted history file.The formatted history file lists data from (b)(6) 2018 to (b)(6) 2021.Unable to complete the functional testing or perform the displacement test, occlusion test and delivery accuracy test due to a completely detached retainer.Device was returned with no allegations.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-0955-2020.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: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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
• 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: 13002056
• MDR Text Key: 284108570
• Report Number: 2032227-2021-230232
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169782396
• UDI-Public: (01)000000643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG2NK8V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• 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: 07/12/2018
• 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-0955-2020
• Patient Sequence Number: 1