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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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-1
Device Problem Defective Alarm (1014)
Patient Problems Fainting (1847); Hypoglycemia (1912); Seizures (2063)
Event Date 09/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Dexcom was made aware on 09/16/2016, that on (b)(6) 2016, the patient experienced intermittent audio ouput and an adverse event. The patient reported that they had alarm delays and only recognized the urgent low alarm. The usual low alarm failed. Patient was hypoglycemic, fainted and had an epileptic seizure. The patient was transferred to the intensive care unit (icu) at the hospital. Additional event or patient information was not provided. No product or data was returned for evaluation. The reported event could not be confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint receiver device was returned for evaluation. The device was visually inspected and no defects were found. Receiver was charged and it passed. A global functional test was performed and it passed. A manual test was performed and speaker sounded. The reported event of an intermittent audio output was not confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
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 Key6022093
MDR Text Key57150816
Report Number3004753838-2016-29490
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5210679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2016
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: 10/12/2016 Patient Sequence Number: 1
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