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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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MEDTRONIC INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Injury (2348); Patient Problem/Medical Problem (2688)
Event Date 12/02/2015
Event Type  Injury  
Event Description
A couple hours after changing an infusion site for my medtronic minimed insulin pump, my blood glucose crashed from 140 mg/dl to less than 20 mg/dl in less than twenty minutes, resulting in a hypoglycemic seizure and hospitalization.My employer maintains its own emt staff because of our remote work location.Had our emts not found me and provided over 200 grams of dextrose to bring me out of the seizure.I would have died.I suffered severe muscle damage from the intensity of the seizure.This muscle damage resulted in rhabdomyolysis and temporary kidney and liver damage.When i called medtronic on (b)(6) 2015 to report the issue, i was transferred to technical support and i was blamed for my own seizure.Today ((b)(6) 2017), medtronic issued an urgent voluntary recall for the infusion sets.I strongly encourage you to consider enforcing a non-voluntary recall to prevent anyone from experiencing the medical trauma that i experienced.
 
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Brand Name
INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6864475
MDR Text Key86241232
Report NumberMW5072127
Device Sequence Number2
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 09/12/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/13/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Weight100
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