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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INFUSION SET

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MEDTRONIC INFUSION SET Back to Search Results
Device Problem Unintended Collision (1429)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 08/29/2017
Event Type  Injury  
Event Description
Blacked out due to low blood sugar after changing my infusion set which resulted in an automobile accident injuring people and totaling vehicles.
 
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Brand NameINFUSION SET
Type of DeviceINFUSION SET
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6865088
MDR Text Key86138983
Report NumberMW5072147
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 09/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 09/14/2017 Patient Sequence Number: 1
Treatment
ADVIL; MULTIVITAMIN ; NOVOLOG INSULIN
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