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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Pneumonia (2011)

Event Date 08/21/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).Insulin pump received with a depleted (b)(6) alkaline battery installed.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.History download was successful using thus and carelink upload was successful.Insulin pump had minor scratched display window, scratched case, torn serial number label, pillowing keypad overlay, stained keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: the formatted history file lists data from (b)(6) 2019 to (b)(6) 2021.

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 multiple organ complications.The cause of death was cardiac arrest and bilateral pneumonia.The customer¿s blood glucose was unknown at the time of death.The customer was not wearing the insulin pump at the time of death as hospital took it off after 1 week in hospital.The customer was not using sensors.The auto mode on the insulin pump was not active and automatically adjusting insulin delivery during the event.The insulin pump was returned for analysis.The case was reported on basis of failure 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 provided with initial report has been updated and provided in b5 section of this report.

Event Description

It was reported that the customer passed on (b)(6) 2021 under hospice care.Customer passed after 5 months in the hospital.Other health issues that might have contributed to passing was multi-organ complications- kidney, lung, and diabetes.Device was last worn on (b)(6) 2021.Device does not have auto mode feature.

Manufacturer Narrative

Retainer ring = clear.Patient passed away on (b)(6) 2021.Device was returned with no allegations.Device received with a depleted kirkland signature alkaline battery installed.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.History download was successful using thus and carelink upload was successful.Device had minor scratched display window, scratched case, torn serial number label, pillowing keypad overlay, stained keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: the formatted history file lists data from (b)(6) 2019 to (b)(6) 2021.Device tested ok.Device returned with no allegations.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

Retainer ring = clear patient passed away on (b)(6) 2021.Pump was returned with cosmetic damage allegations.Unit received with a depleted kirkland signature alkaline battery installed.Unit 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 (b)(4) inches.History download was successful using thus and carelink upload was successful.Unit had minor scratched display window, scratched case, torn serial number label, pillowing keypad overlay, stained keypad overlay and cracked retainer.The test p-cap and reservoir does lock in place in the reservoir compartment.Data analysis: the formatted history file lists data from (b)(6) 2019 to (b)(6) 2021.Device tested ok.Cosmetic damage confirmed for minor scratched display window, scratched case, torn serial number label, pillowing keypad overlay, stained keypad overlay and cracked retainer.(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.

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: 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
• 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: 12497745
• MDR Text Key: 277398845
• Report Number: 2032227-2021-195648
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000190439
• UDI-Public: (01)000000763000190439
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3648N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/29/2021; 02/02/2022; 04/15/2022; 10/14/2019
• Supplement Dates FDA Received: 10/01/2021; 02/11/2022; 05/03/2022; 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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-0955-2020
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male