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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM DEXCOM G4 GLUCOSE SENSOR

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DEXCOM DEXCOM G4 GLUCOSE SENSOR Back to Search Results
Model Number G4
Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Patient Problems Bone Fracture(s) (1870); Hyperglycemia (1905); Hypoglycemia (1912); Complaint, Ill-Defined (2331); Injury (2348); Loss of consciousness (2418)
Event Date 02/28/2016
Event Type  Injury  
Event Description
On (b)(6) while leaving a friend and heading back to my home unbeknownst to me my blood sugar was dropping. I was not being alerted by my dexcom. I had many alerts in the past so i was very familiar with this sort of alert. While driving my sugar dropped further to an unknown level causing me to black out and run head on into another vehicle. I believe it was the 3rd day in the med my girl brought me the letter dexcom mailed warning of the devices failure to alert. The device no longer worked properly after the accident so i could not get an accurate history. Once the barrier died it would not come back to life after that. As my blood sugar wasn't checked at the accident scene the level is still unknown. The fight/flight results raised my blood sugar to high levels as found when it was checked in the trauma unit estimated 1 hout after the initial accident. As a result i have limited use of my right hand. As i am a network engineer this has created quite a hurdle. Crushed left hip, cracked knee cap and crushed/broken right wrist. Other wounds with no lasting effect. To this day i am still pulling glass out of my arms.
 
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Brand NameDEXCOM G4
Type of DeviceGLUCOSE SENSOR
Manufacturer (Section D)
DEXCOM
MDR Report Key5892950
MDR Text Key52747309
Report NumberMW5064212
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberG4
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: 08/17/2016 Patient Sequence Number: 1
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