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

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

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/07/2019

Event Type  Death  

Manufacturer Narrative

"this report is part of a retrospective review and remediation efforts in response to a warning letter.Recall: z-0955-2020.(b)(4).S/w 4.10c.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 0.08710 inches.Unit uploaded properly using carelink.Unit had scratched case, pillowing 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 08/20/2019 to 11/19/2019.

Event Description

Complaints text 02/01/2020 06:57:45 erp_rfc_user related svn (b)(4).Complaints text 02/01/2020 06:57:41 erp_rfc_user related svn (b)(4).Complaints text 02/01/2020 06:57:32 sanchk29 i marked the account inactive/deceased as well as voided the device/pump warranty to reflect the end date as the date the notification was received of customers passing (01/31/2020).I opted out of marketing/account comm.Pref.Complaints text 01/31/2020 09:10:56 erp_rfc_user related svn (b)(4).Complaints text 01/31/2020 09:10:45 marigm2 initial notes: (b)(6) ((b)(6)/husband) called in received invoice and calling to report passing of the patient.Inquired what led up to the complaint.Customer response: husband calling to report the death of the patient.Deceased reporting per (b)(4).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: spouse.Reporting party is aware of the deceased event details.Date of customer passing: (b)(6) 2019.Cause of customer passing as indicated by reporting party: recovering from surgery because she had fallen and has broken bone.Location of customer¿s passing: died in hospital.Date customer was admitted to hospital, emergency room or hospice (if known): admitted in the hospital.Bg at time of admission to hospital, hospice and/or emergency room, (if known): no.Does reporting party indicate other health issues or illness that may have contributed or led up to passing? customer was in dialysis.Does reporting party recall the initial onset or timeframe of health issue or illness? customer fell and broke her bones.She was hospitalize a week before passing.Was pump worn at the time of passing? no.Date the pump was last worn: cant recall the date but it was removed when patient was hospitalized.Reason customer was not wearing pump at time of deceased event: hospital removed the pump to treat patient.Does reporting party know if customer was off pump therapy due to other health issue or illness? "no, maybe because of dialysis".Pump material number: spouse already returned the pump.Pump serial number: can't provide info.Infusion set material number: can't provide info.Infusion set lot/batch: can't provide info.Reservoir material number: can't provide info.Reservoir lot/batch: can't provide info.Name of glucometer being worn or used (ascensia, lifescan, etc.): can't provide info.Was medtronic cgm included in diabetes therapy? no.Husband does not have the result of passing of the patient.Customer's outcome pertaining to the complaint: document information about the passing of the patient.Ship: nothing / return: nothing.

• Brand Name: 630G INSULIN PUMP MMT-1715KR 630G
• 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; * 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: 15039549
• MDR Text Key: 296051594
• Report Number: 2032227-2022-288505
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000173036
• UDI-Public: (01)00763000173036
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/17/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG356EC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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 Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 135