• 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

  • 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 Back to Search Results
Lot Number 5164706
Device Problems Excess Flow or Over-Infusion (1311); Nonstandard Device (1420)
Patient Problems Hypoglycemia (1912); Vomiting (2144); Loss of consciousness (2418)
Event Date 09/14/2017
Event Type  Injury  
Event Description
I started vomiting and was unresponsive. My husband checked my blood sugar and it was 37. He gave me the glucagon, waited 1 min and checked my sugar again. It was 31. He called the ambulance and they took me to (b)(6) hospital. The er had to give me an io because they could not get an iv started. Once i got the io, i started to be responsive again. I was discharged thinking i gave too much insulin at dinner time. On (b)(6) 017, i got a letter in the mail stating my quick-set from medtronic was recalled and to check boxes to see if i had any boxes recalled. I had 6. The recall was because the quick-sets were giving too much insulin. The problem stopped after the person reduced and dose or stopped taking or using the product. The product did not return if the person started taking or using the product again. Reason for use: type 1 diabetes. Dates of use: (b)(6) 2017, subcutaneously.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMINIMED QUICK-SET PARADIGM
Type of DeviceMINIMED QUICK-SET PARADIGM
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6883309
MDR Text Key87155157
Report NumberMW5072260
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 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2019
Device Lot Number5164706
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: 09/20/2017 Patient Sequence Number: 1
-
-