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 Problem Renal Failure (2041)

Event Date 08/28/2021

Event Type  Death  

Manufacturer Narrative

(b)(4). Retainer ring
=
clear, 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. 0871 inches. History download was successful using thus and (b)(6) upload was successful. Unit had minor scratched display window, scratched display window cover, scratched case, cracked battery tube threads, cracked case at the battery tube side, pillowing keypad overlay, cracked keypad overlay at the select button and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment.

Event Description

Customer¿s daughter reported via phone call that the customer passed away in hospital. The customer was hospitalized on (b)(6) 2021 due to covid. The caller stated that the cause of death was covid, kidney failure. 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. The insulin pump had been disconnected 48 hours prior to passing. The caller agreed to return the insulin pump for analysis.

Manufacturer Narrative

Retainer ring
=
clear. Patient passing reported on (b)(6) 2021. Date of customer passing (b)(6) 2021. Device was returned with no allegations. The device did not have a battery installed when received. 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. 0871 inches. History download was successful using thus and carelink upload was successful. Device had minor scratched display window, scratched display window cover, scratched case, cracked battery tube threads, cracked case at the battery tube side, pillowing keypad overlay, cracked keypad overlay at the select button and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment. Data analysis: (b)(6) 2021 daily total of all insulin delivered
=
51. 575; (b)(6) 2021 daily total of all insulin delivered
=
22. 375; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30; (b)(6) 2021 daily total of all insulin delivered
=
30. Device tested ok with no device problems found. Device was returned with no allegations.

• 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: 12577915
• MDR Text Key: 274789129
• Report Number: 2032227-2021-201474
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3BNCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• 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: 04/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: Z-0955-2020

Patient Treatment Data

Date Received: 10/05/2021 Patient Sequence Number: 1