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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Pneumonia (2011)
Event Date 07/31/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is known contributor to the increased risk for developing cardiovascular disease.
 
Event Description
Dexcom was made aware on 08/24/2016, that on (b)(6) 2016, the patient experienced a mild heart attack at approximately 9:30 a. M. Patient's husband thought she was experiencing a low but after giving her juice, decided something else was going on. The patient's husband drove her to the hospital and the issues discovered were heart attack and pneumonia. The patient was administered an i. V. And lasix to drain excess fluid, as well as antibiotics for the pneumonia. Patient reported that at the time of the event, the dexcom continuous glucose monitor (cgm) was working fine. There was no alleged device malfunction. No additional event or patient information was provided. No product or data was returned for investigation. The reported event could not be confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE 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 Key5959137
MDR Text Key54990572
Report Number3004753838-2016-80313
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
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2016
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?
Event Location No Information
Date Manufacturer Received08/24/2016
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 Unkown

Patient Treatment Data
Date Received: 09/18/2016 Patient Sequence Number: 1
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