• 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 MEDTRONIC 630G INSULIN PUMP AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND

  • 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 MEDTRONIC 630G INSULIN PUMP AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND Back to Search Results
Model Number MMT-242
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problems Hyperglycemia (1905); Missed Dose (2561)
Event Date 02/21/2021
Event Type  Injury  
Event Description
Insulin not administered; could not control my blood sugar after attaching a new set; when i removed set, noticed insulin coming out at the base of the needle. This caused me to not receive my doses of insulin and my blood sugars to rise into the 300's. There appears to be a faulty connection in the clip where the tubing attaches to the metal needle that accesses the port on my body. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDTRONIC 630G INSULIN PUMP
Type of DeviceAUTOMATED INSULIN DOSING , THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key11372250
MDR Text Key233525178
Report NumberMW5099577
Device Sequence Number1
Product Code OZO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/21/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-242
Device Lot Number5308894
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/23/2021 Patient Sequence Number: 1
-
-