MAUDE Adverse Event Report: MEDTRONIC, INC. MIO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 5278135

Device Problem Defective Component (2292)

Patient Problem Hypoglycemia (1912)

Event Date 08/08/2019

Event Type  Injury  

Event Description

After changing medtronic mio infusion set, blood glucose level increased by 200+ mg/dl over 3-5 hours resulting in hyperglycemia blood glucose levels of 350+ mg/dl.The same problem occurred with 3 infusion sets out of 9 with ref# mmt-923 and lot# 5278135.I believe i have received defective mio infusion sets and they should be recalled.Medtronic has been contacted 3 times regarding the same problem and has not provided the lot numbers of recalled infusion sets for me to compare to the defective infusion sets.Testing should be completed on the mio infusion sets to determine if they are defective.Defective infusion sets caused hyperglycemia.

• Brand Name: MIO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 9069923
• MDR Text Key: 158845188
• Report Number: MW5089790
• 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: 09/03/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2019
• Device Lot Number: 5278135
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR