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 Heart Failure/Congestive Heart Failure (4446)

Event Date 04/29/2022

Event Type  Death  

Event Description

It was reported by the customer's wife via phone call that the customer passed away at home on (b)(6) 2022.The customer was hospitalized on (b)(6) 2022 due to heart problem.The cause of death was heart problem.The caller stated that the customer had heart problem that may have led to the customer's passing.The customer¿s blood glucose was 106 mg/dl at the time of death.The customer was not wearing the insulin pump at the time of death.Customer stated that the reason they were not wearing insulin pump was they wore the insulin pump just when the customer needed it to deliver the insulin.The customer was using sensors.It is unknown if the caller will return the insulin pump for analysis.

Manufacturer Narrative

(b)(4).The customer passed away on (b)(6) 2022.Also, on (b)(4), svn#: 000313942394 - customer returned pump for an alleged blank display and battery cap cracked/damaged found on (b)(6) 2022.The pump powered up properly after battery installation.No damage on the battery cap noted during visual inspection.The pump passed the sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and dat at 0.08735 inches.However, pump error 63 alarm during self test.The pump was monitored for several hours, and no blank display noted.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.Power management graph was successfully generated.The power management tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.No alarms/alerts were noted during the testing.No power error 25 and replace battery alert/replace battery now alarm recorded in the formatted history file for the event date of (b)(6) 2022.However, low battery alert was recorded and found in the formatted history file on: (b)(6) 2022 07:56:00.000 (b)(6) 2022 09:55:08.000 insert battery alarm was recorded and found in the formatted history file on: (b)(6) 2022 08:05:36.000, (b)(6) 2022 08:15:00.000 (b)(6) 2022 09:55:19.000, (b)(6) 2022 10:02:15.000 (b)(6) 2022 10:12:00.000.Power loss alarm was recorded and found in the formatted history file on: (b)(6) 2022 10:13:39.000, (b)(6) 2022 10:13:50.000.And failed batt/battery failed alarm was recorded and found in the formatted history file on: (b)(6) 2022 09:55:08.000.Please see below for the (power data) date range listed in the power management report/detail trace file.The power management report/detail trace file lists data from 4/27/2020 at 10:59:58 am to (b)(6) 2020 at 4:58:00 pm and (b)(6) 2020 6:24:00 am to (b)(6) 2022 at 12:40:01 pm.There was no data available to verify power data for low battery alert, power loss alarm and failed batt/battery failed alarm.Pump error 63 alarm (variableinfo = 03) was recorded and found in the formatted history file on (b)(6) 2022 12:32:28.000.The keypad overlay was removed to perform visual inspection and found a broken trace on u1 keypad assembly.Pump error 63 alarm (variableinfo = 03) was confirmed due to a broken trace on u1 keypad assembly.The pump was cut open to perform visual inspection and it was verified that the battery tube power connector is properly connected to j7/pcb1.No evidence of physical or moisture damage on the electronic assembly, force sensor, motor and vibrator assembly noted.Force sensor zero offset within specification (23.3 mv).The motor was tested outside of the device on the ngp stb3 and passed.The test p-cap and reservoir locked properly into reservoir compartment.However, a cracked retainer was noted during testing.The following were also noted during visual inspection: a pillowing keypad overlay and a scratched case.The pump was received with a depleted duracell alkaline battery installed.Please see below for the date range listed in the formatted history file.The formatted history file lists data from 12/20/2018 to 04/01/2022.A cracked retainer was confirmed.Blank display was not confirmed.Battery cap cracked/damaged was not confirmed.Pump error 63 alarm was confirmed.Pump error 63 alarm during self test due to broken trace on u1 keypad assembly.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.

Manufacturer Narrative

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.The information that provided with the initial report was incorrect.The correct information has been included with this report in b5 section.

Event Description

It was reported that the insulin pump was returned for analysis.

• 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: 15307299
• MDR Text Key: 298757377
• Report Number: 2032227-2022-316373
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000090197
• UDI-Public: (01)000000763000090197(17)210404
• 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
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2021
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2FG72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• 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 Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 70 KG