MAUDE Adverse Event Report: MEDTRONIC INFUSION SET

Device Problem Unintended Collision (1429)

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

Event Date 08/29/2017

Event Type  Injury  

Event Description

Blacked out due to low blood sugar after changing my infusion set which resulted in an automobile accident injuring people and totaling vehicles.

• Brand Name: INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6865088
• MDR Text Key: 86138983
• Report Number: MW5072147
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADVIL; MULTIVITAMIN ; NOVOLOG INSULIN
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 66