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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 DEXCOM SHARE SYSTEM MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS Back to Search Results
Model Number MT22495
Device Problem Defective Alarm (1014)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 03/20/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and seizures.
 
Event Description
Patient's wife contacted dexcom on (b)(6) 2016 to report an adverse event that occurred on (b)(6) 2016. Patient's wife stated that the patient had a seizure due to being hypoglycemic. The paramedics were called and the patient was treated at home. Paramedics administered glucose gel and food. Patient's blood glucose was at 100mg/dl when the paramedics left. Patient's wife reported that there were was no audio output from the receiver during the event. Additionally, patient's wife tested the receiver and the alarms did work. At the time of contact, the patient was in good condition. No additional event or patient information was reported.
 
Manufacturer Narrative
(b)(4) describe event or problem - additional, device available for evaluation - additional, additional information/device evaluation, device evaluated by manufacturer - additional, event problem and evaluation codes - additional.
 
Event Description
The complaint device was returned for evaluation. The device was externally visually inspected and no defect was found. A review of the downloaded receiver log did not find any issues related to the customer complaint. Functional testing and the test failed. The reported event of an intermittent audio output. The root cause was determined to be a defective speaker assembly.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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 Key5585860
MDR Text Key42938719
Report Number3004753838-2016-02507
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTR-DR-001
Device Lot Number5210017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/18/2016 Patient Sequence Number: 1
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