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

Model Number MMT-925

Device Problem Nonstandard Device (1420)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Numerous unexplainable low blood sugars that rendered me unconscious.Caused seizing of my body and brain damage.Needed emergency paramedic help 2 to 3 times while using the recalled mio infusion sets.

• Brand Name: MIO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6864579
• MDR Text Key: 86241092
• Report Number: MW5072128
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2018
• Device Model Number: MMT-925
• Device Lot Number: 5160817
• 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): Life Threatening; Other; Required Intervention
• Patient Weight: 70