MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC INFUSION SETS

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Sweating (2444); Confusion/ Disorientation (2553)

Event Date 07/26/2017

Event Type  Injury  

Event Description

I am diabetic and wear a medtronic insulin pump.Went to bed with a blood sugar of 180.Woke up 2 hours later with my husband standing over me, completely drenched in sweat.He said he had been up with me for 30 minutes giving me 2 glasses of juice to drink.He was surprised i could actually drink it because i was basically passed out and have no recollection of the past 30 minutes.After my 2 glasses of juice, he tested my blood sugar and it was 56.He said the only reason he woke up is because i yelled out and hit him.Again, no recollection of that.If he had not woken up or if i had been home alone that night, i would have died.Not a very fun thought.

• Brand Name: MEDTRONIC INFUSION SETS
• Type of Device: MEDTRONIC INFUSION SETS
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6897744
• MDR Text Key: 87653875
• Report Number: MW5072493
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397
• Device Lot Number: 5170718
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 68