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

Model Number MMT-387T

Device Problems Kinked (1339); Failure to Deliver (2338); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

Note: 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 she received an insulin flow blocked alarm.Customer reported that they observed the insulin collecting at the infusion set quick release.During troubleshooting, customer disconnected at the quick release and performed a fill cannula.Customer noted that the insulin did not exit, but collected at the quick release.Customer then removed the infusion set and observed a kinked infusion set cannula.Customer tried another infusion set and observed that insulin was collecting at the quick release.Customer had a blood glucose of 385 mg/dl at the time of the incident.Product 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: 6978480
• MDR Text Key: 90853184
• Report Number: 2032227-2017-61630
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-387T
• Device Catalogue Number: MMT-387T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 54