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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 9500-27
Device Problems Use of Device Problem (1670); Invalid Sensing (2293)
Patient Problems Hypoglycemia (1912); Tachycardia (2095); Weakness (2145)
Event Date 11/18/2016
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 (b)(6) 2016, that on (b)(6) 2016, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event. The patient reported that when he experiences hypoglycemia, the cgm takes a long time to match the glucometer. Patient reported that when the cgm read "low" and he was feeling weak and had tachycardia, he treated it by eating the appropriate amount of carbs and approximately 30 minutes later he took a fingerstick that read 92mg/dl while the cgm still read "low. " additional event or patient information is not available. No product or data was provided for evaluation. The reported event of cgm inaccuracies could not be confirmed. A root cause could not be determined. Labeling indicates: do not use the dexcom g4 platinum system for treatment decisions, such as how much insulin you should take. The dexcom g4 platinum system does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value.
 
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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 Key6183527
MDR Text Key62669253
Report Number3004753838-2016-88709
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 11/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
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 Received11/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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