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

Model Number MMT-864T

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

This is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 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 they had an infusion set tubing detachment.Customer states that the location of the detachment was the connection with the reservoir.Customer's blood glucose level at the time of the incident was 10 mmol/l.The infusion set had been in use for 1 day.The infusion set is expected to be returned.

• 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 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: 7206268
• MDR Text Key: 97969356
• Report Number: 2032227-2018-00836
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: MMT-864T
• Device Catalogue Number: MMT-864T
• Device Lot Number: 5136418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• 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