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 Break (1069); Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 11/06/2021

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 customer was in emergency room due to low blood glucose on (b)(6), 2021.Blood glucose at the time of event was 40 mg/dl.Current blood glucose was 122 mg/dl.Customer had been using the insulin pump system within 48 hours of reported high blood glucose event.Customer had symptoms had shaking and sweating.Based on customer report customer alleged insulin pump was over delivering.The insulin pump will be returned for analysis.

Manufacturer Narrative

On (b)(6) 2021 the customer alleged was hospitalized for low blood glucose, did not received alert, gave too much insulin and slight crack where the battery goes.The test p-cap locks properly in place in the reservoir compartment noted.Device receive with pillowing keypad overlay, cracked case behind the insulin pump at the battery compartment and cracked battery tube threads during the visual inspection.Thus and carelink software was utilized and downloaded trace/history files properly.In further full review of the device history on the event date of (b)(6) 2021 found multiple bolus deliveries and the daily total of bolus insulin delivered are 10.9 units.Also on (b)(6) 2021 found multiple bolus deliveries and the daily total of bolus insulin delivered are 10.8 units.Device 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 delivery accuracy test at 0.08720 inches.The test guardian link with the glucose sensor simulator communicated properly with the insulin pump noted.Device programmed with alert before low and suspend on low and all alerts functioning properly.Device 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 (22.3 milivolts).The motor was tested outside of the device on the next generation insulin pump stb3 and passed.In summary, insulin pump passed all required testing.Unable to verify customer complaint for low blood glucose.The insulin pump over delivery not confirmed noted.The force sensor is within specification and the motor functioning properly.Cosmetic damage was confirmed case behind the insulin pump at the battery compartment and battery tube threads.Customer allegation not confirmed for did not received alert and insulin pump over delivery.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: 12801796
• MDR Text Key: 280690925
• Report Number: 2032227-2021-217465
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)230612
• 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: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4DQAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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: FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 111 KG