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

MAUDE Adverse Event Report: MEDTRONIC 630G INSULIN PUMP

  • 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 630G INSULIN PUMP Back to Search Results
Model Number 630G
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Fall (1848); Hypoglycemia (1912); Laceration(s) (1946); Nerve Damage (1979); Overdose (1988); Pain (1994); Loss of Range of Motion (2032); Seizures (2063); Injury (2348); Loss of consciousness (2418)
Event Date 02/24/2017
Event Type  Injury  
Event Description

A 630g insulin pump emptied entire reservoir, severe hypoglycemic event. Unconscious for 5. 5 hours, fall, seizure, tongue lacerations. Pump showed 83 units of insulin in the reservoir but the reservoir was empty. Two days after pt was hospitalized for rhabdomyolysis. Sustained injury to right elbow, right thumb and right wrist, sl joint, lower back pain. Cognitive and dexterity deficits. Received physical therapy for sl and lower back and issues have resolved. Received splinting for right wrist and thumb and elbow, steroid injections. Failed therapy and now scheduled for surgery for nerve decompression and tendons. Reported issues to medtronic and called back and reported hospitalization. Insulin pump was sent back to medtronic for analysis. Was told that it would be up to 12 weeks before i received analysis of what happened to the pump. Still have not heard back from medtronic and it has been almost 6 months. Have enlisted the help of medtronic rep to find out what is going on but still no answers. Have incurred and will incur lost wages, sick time, out of work and have increasing out of pocket medical bills due to this event with the 630g insulin pump. Cognitive and dexterity issues still requiring time to see if they resolve or will be permanent.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name630G
Type of DeviceINSULIN PUMP
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6803252
MDR Text Key83198210
Report NumberMW5071656
Device Sequence Number0
Product Code OZO
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 08/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2017
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Device MODEL Number630G
Was Device Available For Evaluation? No
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: 08/16/2017 Patient Sequence Number: 1
-
-