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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seizures (2063); Loss of consciousness (2418)
Event Date 09/25/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of unconsciousness.
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an adverse event. The certified diabetes educator (cde) reported that they patient met with the patient at the doctor's office on (b)(6) 2017 regarding health insurance information for a trial device. On (b)(6) 2017, the cde checked in with the patient and was informed that the patient had spent the night in the emergency room (er) on (b)(6) 2017. The patient stated that the event involved his blood sugar and thinks that he had seizures. The patient further stated that he was out cold when the event happened. Additionally, it was indicated that at the time of contact, the patient was still wearing the dexcom system but there was no allegation against the trial device. No additional patient or event information is available. Data was provided for evaluation. There was no allegation against the cgm that was reported, although the patient was wearing the system on the incident date. Data investigation of the patient's studio data was conducted to review events on the date of incident. A review of patient's diagnostic charts shows that the patient experienced estimated glucose values below 50 mg/dl and egvs over 375 mg/dl. No root cause to be determined as there was no allegation against the system.
 
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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 Key6969006
MDR Text Key89980599
Report Number3004753838-2017-94203
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 health professional,other
Reporter Occupation
Type of Report Initial
Report Date 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/23/2017 Patient Sequence Number: 1
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