MAUDE Adverse Event Report: MEDTRONIC PARADIGM 723 VERSION; GLUCOSE SENSOR

Model Number 2.5B1.1

Device Problems Fluid/Blood Leak (1250); Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Diabetic Ketoacidosis (2364)

Event Date 12/31/2013

Event Type  Injury  

Event Description

Issued medtronic paradigm 723 version insulin pump, have had continuous issues with leaking and delivering inappropriate amounts of insulin.This has been reported numerous times to the company, physician and medtronic rep with no remedies.Have been hospitalized in (b)(6), have unpredictable blood sugar highs and lows.Have heard there may be recalls but have not been contacted.

• Brand Name: PARADIGM 723 VERSION
• Type of Device: GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5608336
• MDR Text Key: 43761985
• Report Number: MW5061870
• Device Sequence Number: 1
• Product Code: CGA
• 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: 04/21/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2.5B1.1
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 82