MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-975T

Device Problems Bent (1059); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on october 1, 2017.Subsequently, medtronic diabetes conducted a two year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.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

Customer reported via phone call that she had an infusion set leak.Customer also reported kinked infusion set tubing on two separate infusion sets.Customer also reported observing a bent infusion set cannula upon removal of one infusion set.Customer's blood glucose level at the time of the incident was unknown.The infusion set is not expected to be returned.

• Brand Name: INFST MM T-975T MIO 2PK 9MM 32IN CLEAR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7246236
• MDR Text Key: 99327427
• Report Number: 2032227-2018-01290
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-975T
• Device Catalogue Number: MMT-975T
• Device Lot Number: G116P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• 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