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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINI MED MEDTRONIC QUICK SET PARADIGM INFUSION SET
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MEDTRONIC MINI MED MEDTRONIC QUICK SET PARADIGM INFUSION SET Back to Search Results
Lot Number 5144230
Device Problem Computer Operating System Problem (2898)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
Event Date 08/19/2017
Event Type  Injury  
Event Description
On (b)(6) 2017 i changed my paradigm infusion set at approximately 12:10 am before i went to bed.At approximately 2 am i went into a seizure.By the time my boyfriend woke up it was the last seizure point and in convulsions, eyes rolled in the back of my head, barely breathing, and unresponsive.This not being the first time this has happened to me while i was sleeping, he ran to the fridge and got a glucagon kit and called 911.Panicking the glucagon shot broke and he had to run and get another.Firefighters and ambulance showed up to give me medical attention.It took me a good 25 - 30 minutes to come to.This last episode was the worst one yet.I'm lucky to still be alive with how many times this has happened to me.Ironically enough the set that i used the night of this last episode has been recalled.Frequency: 3 times a day.How was it taken or used: respiratory (inhalation).
 
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Brand Name
MEDTRONIC QUICK SET PARADIGM INFUSION SET
Type of Device
MEDTRONIC QUICK SET PARADIGM INFUSION SET
Manufacturer (Section D)
MEDTRONIC MINI MED
MDR Report Key6935713
MDR Text Key89149501
Report NumberMW5072661
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 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/30/2019
Device Lot Number5144230
Other Device ID NumberMMT-397
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age22 YR
Patient Weight63
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