MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KL

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 11/05/2021

Event Type  Injury  

Event Description

The customer reported via phone call that they were dispatched from emergency medical services due to low blood glucose levels on (b)(6), 2021.Customer's blood glucose was 38 mg/dl at the time of incident.Customer had low blood glucose when paramedics came and they treated customer's low blood glucose with food and glucose tablets.Customer was also treated with glucagon.Customer's current blood glucose was 256 mg/dl.Customer was assisted with troubleshooting.Customer alleged that the insulin pump was over delivering insulin because emergency medical team told customer that something could be wrong with their insulin pump.Customer had been using the insulin pump system within 48 hours of reported low blood glucose event.The insulin pump and reservoir will be returned for analysis.

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Manufacturer Narrative

S.W version 4.11c.Retainer ring = black.Customer returned pump for an alleged possible over delivery and ems dispatched for low bgs found on (b)(6) 2021.Also on (b)(4), svn#: 000313572608 - customer returned pump for an alleged low bgs found on (b)(6) 2021 and on (b)(4), svn#: 000313572624 - customer returned pump for an alleged high bgs found on (b)(6) 2021.The pump passed the functional tests, 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 dat at 0.08720 inches.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.In further full review of the pump history on the event date of (b)(6) 2021, there is no unexpected alarms/suspends and found manual bolus/bolus wizard delivery of daily total of bolus insulin delivered = 24.35 u bolus.On (b)(6) 2021 08:05:36.000 normal bolus delivered.Normal bolus amount programmed = 1.3.Bolus amount delivered = 1.3.On (b)(6) 2021 09:43:33.000 normal bolus delivered.Normal bolus amount programmed = 5.45.Bolus amount delivered = 5.45.On (b)(6) 2021 11:36:22.000 normal bolus delivered.Normal bolus amount programmed = 2.75.Bolus amount delivered = 2.75.On (b)(6) 2021 11:41:01.000 normal bolus delivered.Normal bolus amount programmed = 1.3.Bolus amount delivered = 1.3.On (b)(6) 2021 16:35:03.000 normal bolus delivered.Normal bolus amount programmed = 4.55.Bolus amount delivered = 4.55.On (b)(6) 2021 17:24:07.000 normal bolus delivered.Normal bolus amount programmed = 2.Bolus amount delivered = 2.On (b)(6) 2021 17:25:55.000 normal bolus delivered.Normal bolus amount programmed = 2.Bolus amount delivered = 2.On (b)(6) 2021 21:45:17.000 normal bolus delivered.Normal bolus amount programmed = 4.3.Bolus amount delivered = 4.3.On (b)(6) 2021 23:31:49.000 normal bolus delivered.Normal bolus amount programmed = 0.7.Bolus amount delivered = 0.7.The pump was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts (at quick bolus speed) and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the pcba1, pcba2, force sensor, motor and vibrator assembly noted.Force sensor zero offset within specification (22.7 mv).The motor was tested outside of the device on the ngp stb3 and passed.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: a pillowing keypad overlay and a scratched case.The pump passed all the required testing.Unable to verify customer alleged for high bgs and low bgs.The force sensor is within specification and the motor functioning properly.Customer alleged for possible over delivery was not confirmed.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 of 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-1715KL 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: 12786315
• MDR Text Key: 280573363
• Report Number: 2032227-2021-216478
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)230706
• 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: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4FRM9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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: UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 52 KG