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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED MIO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameMINIMED MIO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6864719
MDR Text Key86285563
Report NumberMW5072138
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received09/13/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Model NumberMMT-923
Device Lot Number5127871
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
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