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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 MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-35
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Fatigue (1849); Weakness (2145)
Event Date 01/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Distributor contacted dexcom on behalf of patient on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event that occurred on (b)(6) 2016. Sensor was inserted on (b)(6) 2016. It was reported that after breakfast, the patient decided to going for a one hour brisk walk. The patient's bg level was around 9mmol/l and she lowered her total basal insulin dosage (tbd) prior to her walk. After about 10 minutes, the receiver showed a single arrow and then a double arrow. The patient reported that the receiver displayed increasing values from 10. 3mmol/l to 11. 16mmol/l to 15. 3mmol/l. Shortly after, the patient then turned off her tbd, took a small bolus dose, and saw that the receiver displayed 17mmol/l. After 40 minutes, the cgm continued to stay at 17mmol/l and the patient thought it was strange that her bg level had not dropped. The patient thought it may have been contributed to the fact that she took too small of a bolus dosage and that she had a cold. About 2 minutes after, the cgm displayed the error reading symbol and knew something was wrong. The patient began to feel weak in her legs, but arrived home about 5 minutes later. She checked her bg level with a bg meter and it displayed 2. 9mmol/l, so she got something to eat and then felt better. No additional event information or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5455990
MDR Text Key38853381
Report Number3004753838-2016-25422
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-35
Device Catalogue NumberSTS-GL-006
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 Received03/18/2016
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: 02/23/2016 Patient Sequence Number: 1
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