MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number MMT-332A

Device Problems Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 04/08/2023

Event Type  Injury  

Event Description

Information received by medtronic indicated that the customer had hyperglycemia along with hospitalization on april 09 2023,  the blood glucose value during time of hospitalization was 600 mg/dl.Currently, the blood glucose value was 126 mg/dl.Customer reported leakage on the reservoir barrel along with the air bubbles.Customer had symptoms of vomiting, other, confused, sleepy.The customer was using the insulin pump system within 48 hours of reported high blood glucose event and the auto-mode/smartguard feature was not active at the time of high blood glucose event.No further patient complications were reported.Troubleshooting was performed, customer reported high blood glucose event was treated with insulin pump and iv insulin drip (intravenous insulin infusion) at hospital.Customer was tested for ketons and found out that customer was diagnosed with dka and the issue was not resolved.The customer will discontinue use of the device.The 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.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: RESERVOIR 3ML MMT-332A
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: justin ellis ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635265677
• MDR Report Key: 16805119
• MDR Text Key: 313899056
• Report Number: 2032227-2023-195477
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 002076300027335801
• UDI-Public: (01)002076300027335801(17)251105(10)HG6N2V3
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG6N2V3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2023
• Initial Date FDA Received: 04/25/2023
• Date Device Manufactured: 11/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: FRN-MMT-332A-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG