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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
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Concussion (2192)
Event Date 03/03/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Patient's trainer contacted dexcom on (b)(6) 2016 to report an adverse event that occurred on (b)(6) 2016. Patient was working out and while running, went from 100mg/dl to below 30mg/dl and hit her head. Patient's trainer treated her with glucose tablets and (b)(4). The trainer determined that the patient had a concussion. The following day, (b)(46) 2016, the patient saw the doctor onsite and they also diagnosed a concussion. The patient was not wearing the dexcom continuous glucose monitor (cgm) at the time of the event. There was no alleged device malfunction. No additional event or patient information was provided.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom received additional information regarding a patient's allergic reaction that occurred on (b)(6) 2015. It was reported that the patient experienced a contact allergy from the cyanoacrylate used in the production of the sensor patch. Cyanoacrylate is present in the glue used to attach the housing of the sensor to the top (non-skin adhering side) of the patch. Patient's parent believes that the cyanoacrylate may migrate to the adhesive touching the skin, before it has hardened, coming into direct contact with the patient's skin. Patient's doctor concluded that the patient experienced an allergic reaction to the cyanoacrylate contained in the glue, used to adhere the sensor pod to the top of the mesh of the patch and not the adhesive that adheres directly to the skin.
 
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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 Key5536824
MDR Text Key41511167
Report Number3004753838-2016-02098
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 03/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2016
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 Initial

Patient Treatment Data
Date Received: 03/30/2016 Patient Sequence Number: 1
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