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

Model Number	MMT-1715KR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	05/22/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.
Event or Problem Description
Complaints text 06/15/2020 17:24:00 albana5 initial notes: customer received another envelope for returning the pump.The pump was already returned last week.Customer only used the box and the ups sticker, no letter envelope was used.Pump still shows in not received yet inquired what led up to the complaint.Customer response: customer received another envelope for returning the pump.The pump was already returned last week.Customer only used the box and the ups sticker, no letter envelope was used.Pump still shows in not received yet customer's outcome pertaining to the complaint: advised customer the letter envelope was supposed to be used to return the pump.The box was supposed to go in the letter envelope while the ups sticker was meant to be placed outside the le.Ship: nothing / return: nothing.Complaints text 06/08/2020 08:41:46 mollaa1 i marked the account inactive/deceased (while opting out of all communications) as well as voided the medtronic device warranty.See s/o transaction (b)(4) and the ups campusship return request for the return of the referenced device to medtronic.Tracking number: (b)(4) service: ups next day air label delivery method: print and mail return label.Complaints text 06/08/2020 08:11:05 ramirc46 customer called in stating he reported the death of his partner already but never rec the return packaging.None shown for return yet on acct was shipped.Reached out to our solutions and was able to get it shipped out today to the address confirmed on notes; (b)(6) advised will be a ups return packaging and pre-paid return labels will be shipped and delivered within (3) three business days.Place the products in the return packaging provided and attach a pre-paid return label.Once return label is attached, package can be taken to local ups store, delivered to a ups drop box or contact ups directly for pick up.Understood.Complaints text 06/01/2020 10:52:57 erp_rfc_user related svn (b)(4).Complaints text 06/01/2020 10:52:37 cabram5 initial notes: deceased reporting called is kevin parker, life long partner inquired what led up to the complaint.Customer response: deceased reporting deceased reporting per dop114-980.First and last name of person reporting event: (b)(6).Best phone number to reach person reporting event: (b)(6) relationship of person reporting event to the deceased: life long partner.Reporting party is aware of the deceased event details.Date of customer passing: (b)(6) 2020.Cause of customer passing as indicated by reporting party: heart failure.Location of customer¿s passing: fawcett memorial hospital.Date customer was admitted to hospital, emergency room or hospice (if known): (b)(6) 2020.Bg at time of admission to hospital, hospice and/or emergency room, (if known): does not know.Does reporting party indicate other health issues or illness that may have contributed or led up to passing? does not know.Does reporting party recall the initial onset or timeframe of health issue or illness? does not know.Was pump worn at the time of passing? yes.Pump material number: does not know.Pump serial number: does not know.Infusion set material number: does not know.Infusion set lot/batch: does not know.Reservoir material number: does not know.Reservoir lot/batch: does not know.Name of glucometer being worn or used (ascensia, lifescan, etc.): does not know.Was medtronic cgm included in diabetes therapy? no.Reporting party is unable to complete carelink upload.Reason reporting party is unable to complete carelink upload: does not know how and does not want to.Requested return of mdt system in use at time of deceased event.Adv pump will undergo destructive testing and product cannot be returned.Caller agreed to return product.Name for shipment of product return materials: (b)(6).Address for shipment of product return materials: (b)(6).Phone number for shipment of product return materials: (b)(6).Explained return instructions.Customer's outcome pertaining to the complaint: deceased reporting additional notes: deceased reporting.

• Brand Name: 630G INSULIN PUMP MMT-1715KR 630G
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 15038554
• Report Number: 2032227-2022-289679
• Device Sequence Number: 5102532
• Product Code: OZO
• UDI-Device Identifier: 00763000173036
• UDI-Public: (01)00763000173036
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG304DX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• 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-0955-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 195