MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-398T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-398T

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 01/31/2017

Event Type  Injury  

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 they had an infusion set leak.Customer states that the location of the leak was leaking through the plastic of the infusion set tubing where the tube connects to circular part on body.Customer also reported receiving a no delivery alarm.Customer's blood glucose level at the time of the incident was 525 mg/dl.The infusion set is not expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-398T
• 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: 7213013
• MDR Text Key: 98001099
• Report Number: 2032227-2018-00925
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20643169174331
• UDI-Public: (01)20643169174331(017)20171201
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2017
• Device Model Number: MMT-398T
• Device Catalogue Number: MMT-398T
• Device Lot Number: 002971554T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Date Device Manufactured: 05/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 42