MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC MINI-MED 630G; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number MINI-MED 630G

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 02/01/2019

Event Type  Injury  

Event Description

I used a medtronic mini-med 630g.Woke up about 2 am with low that went from bad to worse.Spent 2 hrs at home trying everything possible to get bs numbers up after eating 3000 calories and consuming a gallon of pure sugar liquid, i couldn't get above 45 on my tests and then i kept dropping into the 30's and so low it wouldn't even register.Went to the er about 4:30 am.Was hooked up to an iv and given several bags of glucose.Got moved to icu where i stayed until the evening when my numbers finally started going up.The only explanation was that the pump malfunctioned and i got an overdose of insulin.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC MINI-MED 630G
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 9799645
• MDR Text Key: 182547503
• Report Number: MW5093551
• Device Sequence Number: 1
• Product Code: OZO
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MINI-MED 630G
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 21 YR