MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-399T

Device Problems Partial Blockage (1065); High Test Results (2457); Device Displays Incorrect Message (2591)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 04/12/2018

Event Type  Injury  

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's mother reported via phone call that her son was hospitalized due to experiencing an episode of diabetic ketoacidosis.Customer's blood glucose level at the time of hospitalization due was 600 mg/dl.Customer's mother reported that her son was treated with a manual drip of insulin.Customer's current blood glucose level is 200 mg/dl.Customer's mother also reported a past event of receiving an insulin flow blocked alarm that was resolved by a complete infusion set change including the reservoir and the infusion set.The infusion set is not expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-399T
• 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: 7440566
• MDR Text Key: 105837353
• Report Number: 2032227-2018-02620
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-399T
• Device Catalogue Number: MMT-399T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Weight: 59