MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-397T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-397T

Device Problems Air Leak (1008); Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 09/03/2017

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 has been struggling to control her blood glucose levels for several days.Customer's blood glucose at time of incident was 251 mg/dl.Customer's current blood glucose is 359 mg/dl.Customer reports that elevated blood glucose levels have persisted through three infusion set changes.Customer reports air bubbles approximately the size of a one quarter of an inch in the infusion set tubing.Customer also reports seeing cloudy condensation in the tubing.Customer reports that infusion set will work for the first day, but that they will begin to experience elevated blood glucose on the second day of wearing an infusion set.Customer does not report experiencing any other symptoms related to elevated blood glucose.Product is expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-397T
• 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: 6974800
• MDR Text Key: 90535939
• Report Number: 2032227-2017-61248
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397T
• Device Catalogue Number: MMT-397T
• Device Lot Number: 5173486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2017
• 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
• Patient Age: 46 YR
• Patient Weight: 91