MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 670G INSULIN PUMP MMT-1780KL; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1780KL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	07/14/2019
Type of Reportable Event	Death
Event or Problem Description
(b)(4) created rma to receive in infusion set and reservoirs received in with pump.Ship: nothing / return: mmt-864 / mmt-332a (b)(4) referenced report provided to medtronic other (b)(6) 2019 forwarded to medtronic technical support department | incident date from (b)(6) 2019.Start report.Customer's wife would like to return the customers pump and does not want it back.Send box to: (b)(6) end report.Outcome: return is already being processed.(b)(4) campusship return request for the return of the device/pump to medtronic.(b)(4) corrected to reflect the proper infusion set product id and batch number as well as svn (b)(4) corrected to reflect the proper batch number.(b)(4) i updated the svn to reflect the proper reported by type and reported by since the spouse/(b)(6) of the customer contacted the medtronic 24-hour technical support department to provide the death report.(b)(4) initial notes: customer's wife called and said she received a call about her deceased husbands pump and she does not know what to do.Inquired what led up to the complaint.Customer response: pos notified of customer passing.Wife was contacted to information regarding the events of customer's death.Deceased reporting per (b)(4).First and last name of person reporting event: (b)(6).Relationship of person reporting event to the deceased: wife.Reporting party is aware of the deceased event details.Date of customer passing: (b)(4) 2019.Cause of customer passing as indicated by reporting party: metastatic lung cancer.Location of customer¿s passing: skilled nursing care facility.Date customer was admitted to hospital, emergency room or hospice (if known): (b)(6) 2019.(b)(6) at time of admission to hospital, hospice and/or emergency room, (if known): unknown.Does reporting party indicate other health issues or illness that may have contributed or led up to passing? lung cancer and diabetes.Does reporting party recall the initial onset or timeframe of health issue or illness? (b)(6) 2019.Was pump worn at the time of passing? no.Date the pump was last worn: (b)(6) 2019.Reason customer was not wearing pump at time of deceased event: removed from the pump because he could no longer manage the pump.Does reporting party know if customer was off pump therapy due to other health issue or illness? removed due to customer not being able to manage the pump any longer.Pump material number: mmt-1780kl.Pump serial number: (b)(41).Infusion set material number: mmt-397.Infusion set lot/batch: 656232.Reservoir material number: mmt-332a.Reservoir lot/batch: hg1l396.Name of glucometer being worn or used (ascensia, lifescan, etc.): ascensia contour 2.4 meter.Was medtronic cgm included in diabetes therapy? yes.Was cgm worn at time of event? no.Customer's outcome pertaining to the complaint: customer's wife wants to return the customers pump.Will ship pump box and envelope ship: 1 sm box 1 le/return: nothing (b)(4) rep from the medtronic (sales) department was notified of the customer passing on (b)(6) 2019.Report deceased patient (b)(6) passed away this past week.He had been ill with cancer.Per obituary, date of passing is (b)(6) 2019.End report.1st attempt - attempted to contact next of kin.Contact unsuccessful.(b)(4).Ceasing all marketing comms.I marked the account in active/deceased.Helpline instructions if you receive call back from cust next of kin: please complete death report and update svn notes.Cust account marked inactive/deceased.Ceasing all marketing comms.Pump warranty end date updated to (b)(6) 2019 to reflect the end date as date the customer was reported deceased.
Additional Manufacturer Narrative
"this report is part of a retrospective review and remediation efforts in response to a warning letter.Z-0956-2020.(b)(4).S/w 4.10e.The unit did not have a battery installed when received.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 0.08700 inches.Unit uploaded properly using carelink.Unit had scratched case, pillowing keypad overlay and cracked retainer.Data analysis: (date of customer passing: 07/14/2019.) the formatted history file lists data from 03/17/2019 to 05/31/2019.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: 670G INSULIN PUMP MMT-1780KL
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 15038508
• Report Number: 2032227-2022-289505
• Device Sequence Number: 5102531
• Product Code: OZP
• UDI-Device Identifier: 00763000166526
• UDI-Public: (01)00763000166526(17)220226
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/26/2022
• Device Model Number: MMT-1780KL
• Device Catalogue Number: MMT-1780KL
• Device Lot Number: HG37CMW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0956-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Sex: Unknown