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

Model Number MMT-398T

Device Problems Air Leak (1008); Insufficient Flow or Under Infusion (2182)

Patient Problem Hyperglycemia (1905)

Event Date 12/24/2017

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that they had high blood glucose value.Customer¿s blood glucose value at time of incident was 347 mg/dl and current blood glucose value was 75 mg/dl.Customer treated it manually.Customer alleged the insulin pump of under delivery.Customer also mentioned about leak in the reservoir past first o-ring and air bubbles measuring 5 inches in length in the infusion set tubing.Customer also reported observing a bent infusion set cannula.The infusion set will be returned for analysis.

• 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: 7210898
• MDR Text Key: 97995868
• Report Number: 2032227-2018-00895
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-398T
• Device Catalogue Number: MMT-398T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 64