MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Nausea (1970); Vomiting (2144); Dizziness (2194)

Event Date 10/17/2021

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

It was reported that the customer were experienced low blood glucose.Blood glucose level at the time of the incident was 2.5 mmol/l treated with food.Customer woke up with blood glucose 2.5 mmol/l feeling nauseous.Customers blood glucose was different at different time 2.4 mmol/l, 2.2 mmol/l, 2.3 mmol/l, 1:57am 2.2 mmol/l, 2.4 mmol/l, 2.3 mmol/l and 2.4 mmol/l.Customer drank a juice, ate chocolate, but she was still feeling unwell.Customer had symptoms related to event was dizziness, vomiting.Customer has been using the insulin pump system within 48 hours of reported low blood glucose event.Customer declined to troubleshoot for low blood glucose.Customers last blood glucose reading was 19.2 mmol/l.The insulin pump will not be returned for analysis.

Manufacturer Narrative

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 0.08715 inches.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.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.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 scratched case.A cracked retainer was confirmed.The pump passed all the required testing.Unable to verify customer alleged for low bgs.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: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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: 12710117
• MDR Text Key: 278809631
• Report Number: 2032227-2021-211288
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000253059
• UDI-Public: (01)000000763000253059
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: A000719667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• 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: UNK-FRN-RSVR , UNK-UNOMED INF SET; UNK-FRN-RSVR , UNK-UNOMED INF SET
• Patient Outcome(s): Other