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 Cardiac Arrest (1762); Respiratory Arrest (4461); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Death  

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 Description

Information received by medtronic indicated that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2020 due to kidney failure and cirrhosis.The cause of death was kidney failure and cirrhosis.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 will be returned for analysis.The case is reported only for the f.A results.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0955-2020.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: 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: 13390788
• MDR Text Key: 295704776
• Report Number: 2032227-2022-107001
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000173036
• UDI-Public: (01)000000763000173036
• 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,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG32Y73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• 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 Age: 35 YR
• Patient Sex: Male