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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INSULIN PUMP INFUSION SET

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MEDTRONIC INSULIN PUMP INFUSION SET Back to Search Results
Model Number MINIMED SILHOUETTE
Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 04/04/2017
Event Type  Injury  
Event Description
I am an insulin dependent diabetic pt using medtronic's minimed insulin pump. For years, i noticed that whenever i changed my reservoir and infusion set, i would experience hypoglycemic incidents. This year in the spring i had a severe incident in which i lost consciousness on a day that i had changed my reservoir. My husband called 911. When the medics arrived they took a finger reading of glucose levels which was low but not low enough to cause me to lose consciousness. As i revived they took me to the ambulance where i realized i was having a severe hypoglycemic attack. They gave me glucose in a gel form to keep me conscious as we went to the (b)(6) hospital in (b)(6). I was admitted, treated for the attack and left. I remember this incident vividly as now it comes to light that the medtronic infusion sets from that lot number are being recalled. As you know i could have lost my life. This is very alarming.
 
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Brand NameINSULIN PUMP INFUSION SET
Type of DeviceINSULIN PUMP INFUSION SET
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6875889
MDR Text Key86746168
Report NumberMW5072194
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
Type of Report Initial
Report Date 09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/30/2017
Device Model NumberMINIMED SILHOUETTE
Device Lot Number5175688
Was Device Available for Evaluation? Yes
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: 09/18/2017 Patient Sequence Number: 1
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