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 Problems Excess Flow or Over-Infusion (1311); Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418); Pallor (2468); Confusion/ Disorientation (2553)

Event Date 01/12/2022

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.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

Customer's mother reported via phone call that customer was admitted to hospital on (b)(6) 2021, due to low blood glucose level.The low blood glucose level of customer was 50 mg/dl.The current blood glucose level of customer was 200 mg/dl.Customer¿s blood glucose increased from 60 mg/dl to 300 mg/dl.Customer was using the insulin pump system within 48 hours of reported low blood glucose event.Customer was treated with food or carb intake.Customer was treated with intravenous insulin drip.Customer alleged that the insulin pump was over delivering insulin.Customer had had dizziness, turned pale, confused, uncooperative or not responsive at the time of incident.Customer often experienced error messages when rewinding the insulin pump.Troubleshooting was performed.The reservoir will not be and insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer ring = black.On (b)(6) 2022, the customer alleged the pump over delivery, hospitalized for low bg and error messages when rewinding the pump.The test p-cap locks properly in place in the reservoir compartment noted.Pump received with pillowing keypad overlay and cracked select button 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), 2022, found multiple bolus deliveries that the customer manually programmed and the daily total of bolus insulin delivered are 24.95u.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 0.08720 inches.No unexpected alarms or error during testing or in the pump history noted.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 (23.8 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 error messages when rewinding the pump 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-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: 13265632
• MDR Text Key: 283946197
• Report Number: 2032227-2022-103629
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)230914
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4NP40
• 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: 09/14/2020
• 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 INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 79 KG