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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number MT20649
Device Problem No Audible Alarm (1019)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 03/15/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and seizures.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that they experienced no audio output from the receiver and a hypoglycemic event on (b)(6) 2016. Patient had low blood sugar, 27mg/dl, because the receiver did not beep. The patient's wife found the patient having a seizure, and she called 911. Emergency medical services (ems) arrived and administered glucagon to the patient. Additionally, the patient tested the audio function of the receiver and it did not beep. No additional event or patient information was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and the reported fault could not be reproduced and there was no failure detected. A review of the downloaded receiver log did not find any errors related to the customer complaint. A manual drop test for intermittency was performed and the test passed. The device was determined to be operating within the required specifications without malfunction. The reported event of no audio output was not confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key5592650
MDR Text Key43152474
Report Number3004753838-2016-42702
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649
Device Catalogue NumberSTR-GL-001
Device Lot Number5178455
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2014
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: 04/20/2016 Patient Sequence Number: 1
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