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); Muscle Weakness (1967); Respiratory Arrest (4461)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2022 the customer passed.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 0.0869 inches.The following were noted during visual inspection: minor scratched display window, missing display window cover, scratched case, cracked battery tube threads, cracked case at battery tube side, pillowing keypad overlay, cracked retainer and corroded battery tube.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 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 06/29/2020 to 12/23/2021.The pump passed the functional testing.During visual inspection the pump had a corroded battery tube.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Information received by medtronic indicated that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2021 due to weakness.The cause of death was kidney failure and liver disease.The caller stated that the customer had kidney failure and liver disease that may have led to the customer's passing.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 customer was not using sensors.The insulin pump had been disconnected 18 days prior to passing.The insulin pump will be returned for analysis.The case is reported only for the failure analysis results.

Manufacturer Narrative

Updated analysis summary by (b)(4) on apr 15, 2022 retainer ring = clear.On jan 01, 2022 the customer passed.No allegation to pump defectiveness or bg issue noted.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 0.0869 inches.The following were noted during visual inspection: minor scratched display window, missing display window cover, scratched case, cracked battery tube threads, cracked case at battery tube side, pillowing keypad overlay, cracked retainer and corroded battery tube.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.Device 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 06/29/2020 to 12/23/2021.Device passed the functional testing.During visual inspection the pump had a corroded battery tube.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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: 13412171
• MDR Text Key: 295623619
• Report Number: 2032227-2022-107657
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000173036
• UDI-Public: (01)000000763000173036
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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: HG3LDR8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female