Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED QUICK-SET PARADIGM ; 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 MINIMED QUICK-SET PARADIGM ; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-396
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Hyperglycemia (1905)
Event Date 10/29/2019
Event Type  malfunction  
Event Description
I was wearing a minimed paradigm revel insulin pump.Shortly after lunch, my blood sugar started to rise extremely rapidly and continued to rise over several hours, despite administering multiple insulin boluses.I went to change the infusion set (paradigm quick-set), thinking the cannula was bent.I discovered the tubing was sliced in half.The tubing did not come in contact with anything sharp while i was wearing it.It appears a cut was introduced in the tubing during the mfg process and tubing became fully separated during normal use.Other infusion sets in the package were not impacted.Fortunately, i was able to get my blood sugar, which had risen over 400, back under control with an insulin injection and replacement of infusion set.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUICK-SET PARADIGM
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key9526029
MDR Text Key173206986
Report NumberMW5091917
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 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/01/2021
Device Model NumberMMT-396
Device Lot Number5249471
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/26/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age52 YR
-
-