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 Fatigue (1849); Hypoglycemia (1912); Convulsion, Clonic (2222); Anxiety (2328); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

The customer reported via phone call that they were hospitalized due to low blood glucose on (b)(6) 2022 with blood glucose of 37 mg/dl.The customer's current blood glucose is 242 mg/dl.The customer did experience any symptoms such as shaking, anxiety, mental confusion, weakness as a result of low blood glucose.Customer reported they had epileptic seizure which was caused by low blood glucose level.The customer was treated with food and glucose tablet.It was unknown that the auto mode feature was active at the time of incident.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.Trouble shooting was performed.No further complications were reported.The customer will continue to use the device.

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 related to event has been updated in summary and provided in b5 section of this report.The information related to heath effect clinical codes has been updated and provided in h6 section of this report.

Event Description

The customer reported via phone call that they were hospitalized due to low blood glucose on (b)(6) 2022 with blood glucose of 37 mg/dl.Customer's current blood glucose was 242 mg/dl.The customer experienced other symptoms such as shaking, anxiety, mental confusion, and weakness as a result of the low blood glucose.Customer reported they had an epileptic seizure which was caused by the low blood glucose level.The customer was treated with food and glucose tablets.It was unknown if the auto mode feature was active at the time of incident.Customer had been using insulin pump system within 48 hours prior to reported low blood glucose event.Trouble shooting was performed.The pump will not be returned for analysis.

Event Description

The device was returned for analysis.

Manufacturer Narrative

Customer returned insulin pump for an alleged ems dispatched for low bgs found on feb 09, 2022.Also, on (b)(4), svn#: 000312463190 - customer returned insulin pump for an alleged low battery life or low battery alert and unexpected battery power loss or replace battery alert/replace battery now alarm found on (b)(6) 2021.The insulin pump passed the the self test, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and dat at 0.08695 inches.However, the pump had a high sleep current measurement.Successfully downloaded history files and traces using thus.Successfully uploaded insulin pump to carelink.Power management graph was successfully generated.The loaded voltage (loaded vlith) and the unloaded voltage (unloaded vlith) display at the power graph management tool shows abnormal behavior.No alarms or alerts noted during the testing.No power error 25, low battery alert, replace battery alert/replace battery now alarm recorded in the formatted history file for the event date.However, insert battery alarm was recorded and found in the formatted history file on: (b)(6) 2021 12:02:44.000 (b)(6) 2021 10:18:05.000 (b)(6) 2021 04:05:39.000 to (b)(6) 2021 07:47:20.000 low battery alert was recorded and found in the formatted history file on: (b)(6) 2021 10:11:00.000 (b)(6) 2021 08:36:00.000.Power loss alarm was recorded and found in the formatted history file on: (b)(6) 2021 07:49:47.000 and (b)(6) 2021 07:49:57.00.Insulin pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electrical board, force sensor, motor and vibrator assembly noted.The original electrical board was installed in a test electrical board, case, internal battery and motor.Powered the insulin pump on using the battery simulator and continued testing.The insulin pump failed the sleep current measurement.The original electrical board was installed in a test electrical board, case, internal battery and motor.Powered the insulin pump on using the battery simulator and continued testing.The insulin pump passed the sleep current measurement.The insulin pump had a high sleep current measurement, problem isolated on the electrical board.Force sensor zero offset within specification (22.7 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 cracked keypad overlay, a stained keypad overlay, a pillowing keypad overlay, a scratched case and a cracked case-corner of belt clip rails near the battery tube compartment.A cracked retainer was confirmed.Unable to verify customer alleged for low bgs.The force sensor is within specification and the motor functioning properly.Low battery life or low battery alert and unexpected battery power loss or replace battery alert/replace battery now alarm were confirmed.Low battery life or low battery alert and unexpected battery power loss or replace battery alert/replace battery now alarm, problem isolated on the electrical board.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: 13838033
• MDR Text Key: 288122252
• Report Number: 2032227-2022-168347
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG304DX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• 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
• Treatment: FRN-MMT-332-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female