MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC MINIMED SIHOUETTE CANNULA; SET, ADMINISTRATION INTRAVASCULAR

Model Number MMT-381

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hyperglycemia (1905); Skin Irritation (2076); Swelling (2091)

Event Date 08/18/2018

Event Type  Injury  

Event Description

The medtronic minimed silhouette adhesive caused my son's skin to swell up and turn red, similar to that of a bug bite.After a day, his blood glucose results were poor, 300 mg/dl on the glucometer.The set is the mmt 381 model and lot 5203032.My son has used other sites in the past from other manufacturer and the tape did not cause as much skin irritations.

• Brand Name: MEDTRONIC MINIMED SIHOUETTE CANNULA
• Type of Device: SET, ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 7809301
• MDR Text Key: 118140161
• Report Number: MW5079329
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Model Number: MMT-381
• Device Catalogue Number: MMT-381
• Device Lot Number: 5203032
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 28