• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MIO INFUSION SETS SET, ADMINISTRATION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MIO INFUSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-925
Device Problem Nonstandard Device (1420)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 05/01/2017
Event Type  Injury  
Event Description
Numerous unexplainable low blood sugars that rendered me unconscious. Caused seizing of my body and brain damage. Needed emergency paramedic help 2 to 3 times while using the recalled mio infusion sets.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMIO INFUSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6864579
MDR Text Key86241092
Report NumberMW5072128
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 Received09/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2018
Device Model NumberMMT-925
Device Lot Number5160817
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: 09/13/2017 Patient Sequence Number: 1
-
-