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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number MT20649-1
Device Problem No Audible Alarm (1019)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418); Pallor (2468)
Event Date 06/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Distributor contacted dexcom on 07/07/2016 to report on behalf of patient that the receiver did not produce audio output and an adverse event that occurred on (b)(6) 2016. It was stated that the patient and his family were at home and shortly after breakfast, the mother found that the patient was pale. Patient said he was tired. Patient's mother gave him milk and fruit sugar. After drinking the milk, the patient started to convulse. When the ambulance arrived the patient was unconscious. The ambulance gave him an injection of glucagon. When controlling the receiver it showed 'low' but it had not alarmed. They had the low alarm setting on 5. 0 mmol/l. Additionally, the receiver's audio function was tested and it did not beep. No further event or patient information was provided.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5841621
MDR Text Key50998697
Report Number3004753838-2016-28009
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTR-GL-102
Device Lot Number5210473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3004753838-02/29/16-001C

Patient Treatment Data
Date Received: 08/02/2016 Patient Sequence Number: 1
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