MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-864T

Device Problems Obstruction of Flow (2423); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Skin Inflammation/ Irritation (4545)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

Information received by medtronic indicated that they were on their second day of using their quickset infusion set and when they rode their bike for 20 minutes their blood glucose level went from 10 mmol/l to 23 mmol/l.They were unsure if their infusion set was working.The user bolused with pump.The user has always used the quickset infusion set and was developing an allergy probably to the plastic cannula.The user disconnected and ran a 5-unit fill cannula and insulin exited.The user also removed the site, connected back to tubing, and ran insulin through.The user did not have scar tissue and they were advised it may be a site related issue as insulin exits tubing when disconnected.No further information was provided.The quickset infusion set was not returned for analysis.

• Brand Name: INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 15799017
• MDR Text Key: 303661037
• Report Number: 2032227-2022-360603
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244020733
• UDI-Public: (01)05705244020733(17)220601(10)5285099
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-864T
• Device Catalogue Number: MMT-864T
• Device Lot Number: 5285099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other