MAUDE Adverse Event Report: MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) QUICKSET; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problem Hyperglycemia (1905)

Event Date 02/05/2024

Event Type  Injury  

Event Description

I used medtronic insulin pump infusion sets "quicksets" and had hyperglycemia requiring medical intervention, every set failed, i called to get them replaced and they refused to replace the sets.Medtronic 780g.

• Brand Name: QUICKSET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
• MDR Report Key: 18667671
• MDR Text Key: 335023687
• Report Number: MW5151163
• 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
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White