MAUDE Adverse Event Report: MEDTRONIC / UNOMEDICAL A/S MEDTRONIC MINIMED MIO ADVANCE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problems Hyperglycemia (1905); Missed Dose (2561)

Event Date 02/21/2021

Event Type  Injury  

Event Description

Insulin not administered; could not control my blood sugar after attaching a new set; when i removed set, noticed insulin coming out at the base of the needle.This caused me to not receive my doses of insulin and my blood sugars to rise into the 300's.There appears to be a faulty connection in the clip where the tubing attaches to the metal needle that accesses the port on my body.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC MINIMED MIO ADVANCE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC / UNOMEDICAL A/S
• MDR Report Key: 11372250
• MDR Text Key: 233525178
• Report Number: MW5099577
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/21/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other