MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-387T QCKSTPRDGM 2PK 6MM32N; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-387T

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

Event Type  malfunction  

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.

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 tubing connector.Customer's blood glucose level at the time of the incident was 100 mg/dl.The infusion set had been in use for 1 day at the time of the detachment.The infusion set is not expected to be returned.

• Brand Name: INFST MMT-387T QCKSTPRDGM 2PK 6MM32N
• 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: 7202649
• MDR Text Key: 97724676
• Report Number: 2032227-2018-00799
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20613994761747
• UDI-Public: (01)20613994761747(017)20161201
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2016
• Device Model Number: MMT-387T
• Device Catalogue Number: MMT-387T
• Device Lot Number: 002882689T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2016
• Initial Date FDA Received: 01/17/2018
• Date Device Manufactured: 07/17/2015
• 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
• Patient Age: 31 YR
• Patient Weight: 72