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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 9438-05
Device Problem Wireless Communication Problem (3283)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced a loss of connection and an adverse event. Date of issue is an approximation. The patient stated that they had signal loss on their device that resulted in a hypoglycemic event. It was indicated that the patient passed out and started seizing. The patient's wife administered 2 units of glucagon and the paramedics were not called. At the time of contact, the patient was doing fine. No additional patient or event information is available. The device has been received for evaluation.   a follow-up report will be submitted once the evaluation is complete.  .
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint transmitter device was returned for evaluation. The device was visually inspected and no defect was found. A voltage test was performed and it passed. A functional test was performed and it failed continuity. The reported event loss of connection was confirmed. The 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 Key6907809
MDR Text Key87983544
Report Number3004753838-2017-86138
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000047
UDI-Public10386270000047
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
Type of Report Initial,Followup
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-05
Device Catalogue NumberSTT-GL-003
Device Lot Number5225041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2017
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: 10/02/2017 Patient Sequence Number: 1
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