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 Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Renal Failure (2041)

Event Date 01/18/2020

Event Type  Death  

Event Description

It was reported via phone call that the customer passed away in hospital on (b)(6) 2020. The customer was hospitalized on (b)(6) 2019 due to kidney failure. The cause of death was kidney failure. The caller stated that the customer had kidney issue that may have led to the customer's passing. The customer¿s blood glucose was unknown mg/dl at the time of death. The customer was not wearing the insulin pump at the time of death. The insulin pump had been disconnected on december 28, 2019. The caller was returned the insulin pump for analysis. Frn-mmt-332a , unomed inf set. The case is reported only for the f. A results.

Manufacturer Narrative

(b)(4). S/w 4. 10c. Retainer ring
=
clear. Date of customer passing: (b)(6) 2020. The insulin pump had minor scratched display window, scratched case, pillowing keypad overlay and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment. History download was successful using thus and carelink upload was successful. The 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. 0871 inches. The insulin pump did not have a battery installed when received. Please see below for the date range listed in the formatted history file. The formatted history file lists data from (b)(6) 2019 to (b)(6) 2019. The pump passed the functional testing. 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.

• 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
• 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: 13017082
• MDR Text Key: 282320593
• Report Number: 2032227-2021-231265
• Device Sequence Number: 1
• Product Code: OZO
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG3553L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• 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: 01/31/2019
• 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: 12/16/2021 Patient Sequence Number: 1