MAUDE Adverse Event Report: MEDTRONIC MINIMED MIO SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-923

Device Problems Excess Flow or Over-Infusion (1311); Nonstandard Device (1420)

Patient Problem Hypoglycemia (1912)

Event Date 09/01/2017

Event Type  Injury  

Event Description

My daughter is a type 1 diabetic. I put her to bed at 9:00 pm and hr blood sugar was 186, straight per bg pole and cgm. I gave her 0. 5 u of insulin, which should drop her down to around 160 as her insulin sensitivity factor is 1:50. At 11 pm, i heard her pump alarming and it was suspended on low and had been suspended on low since 10pm. Her blood sugar was 35. I gave her a juice box which brought her up to around 60. I continued to have to give her a juice box ever 2 hours until around 6am when her blood sugars stabilized. There was no explainable reason for why her blood sugars dropped so low or continued to remain so low. A week later, i received a recall notice that medtronics was recalling infusion sets for over-delivery of insulin after a site change. The event of this event, i had just given my daughter a site change and confirmed that her infusion set used was part of the recall.

• Brand Name: MINIMED MIO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6864719
• MDR Text Key: 86285563
• Report Number: MW5072138
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/12/2017

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

Device Operator

• Device Expiration Date: 09/30/2018
• Device Model Number: MMT-923
• Device Lot Number: 5127871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 09/13/2017 Patient Sequence Number: 1