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 Excess Flow or Over-Infusion (1311)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Anxiety (2328); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 11/24/2019

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.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.

Event Description

The customer reported via phone call that they experienced low blood glucose level.Customer's blood glucose level was 20 mg/dl at the time of event.The customer had symptoms of shaking, sweating, anxiety, mental confusion, belligerence, inability to follow simple commons, weakness and fatigue as a result of low blood glucose.Customer treated low blood glucose with food.Customer's current blood glucose level was 237 mg/dl.The customer alleged the pump was over delivering insulin because the customer stated that her blood glucose goes low every single night below 20 mg/dl and its been this way for the last 2 years.Customer performed displacement test and insulin pump passed it.Customer had been using the insulin pump system within 48 hours of reported event.The insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer ring = black.On (b)(6)2019, the customer alleged the pump over delivery, low bg and pump exposed to strong magnet or mri.The test p-cap locks properly in place in the reservoir compartment noted.Pump received with pillowing keypad overlay during the visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review of the pump history on the event date of (b)(6) 2019, there is no data; however on (b)(6) 2020, found multiple bolus deliveries, customer manually programmed and the daily total of bolus insulin delivered are 15.7u.Also no unexpected motor related errors or alarms noted in the pump history.Pump passed 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 0.08700 inches.Pump was cut open to perform visual inspection and found no moisture or component damage on the electronics, force sensor and motor assembly noted.The force sensor offset measured (22.9 mv).The motor was tested outside of the device on the ngp stb3 and passed.In summary, pump passed all required testing.Unable to verify customer complaint for low bg.Customer alleged for the pump over delivery and pump exposed to strong magnet or mri was not confirmed.The force sensor is within specification and the motor functioning properly.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-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: 12922198
• MDR Text Key: 281654386
• Report Number: 2032227-2021-226075
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316631
• UDI-Public: (01)000000763000316631
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG3Z8UW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• 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
• Treatment: UNOMED INF SET.
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 102 KG