MAUDE Adverse Event Report: MEDTRONIC 630G INSULIN PUMP

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.

• Brand Name: 630G
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6803252
• MDR Text Key: 83198210
• Report Number: MW5071656
• Device Sequence Number: 0
• Product Code: OZO
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 08/16/2017
• Is This An Adverse Event Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: 630G
• 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