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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 MT22608-PNK
Device Problem Defective Alarm (1014)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
Event Date 03/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report an adverse event and intermittent audi output that occurred on (b)(6) 2016. The sensor was inserted into the patient's arm on (b)(6) 2016. Patient's mother stated that the receiver did not alert when the patient was experiencing a hypoglycemic event. Blood glucose meter showed the patient was at 32 mg/dl. Within 10 minutes the patient's mother gave 30 carbs of sugar and could not calibrate until the continuous glucose monitor (cgm) was above 40mg/dl. At that point the patient's mother stated the cgm went up to 66mg/dl. Patient's mother calibrated and the fingerstick matched the cgm. Within 30-40 minutes the patient woke up seizing and unconscious for 25 minutes due to the alert never going off. Patient's mother gave the patient glucagon and the patient went up to 83mg/dl. Patient's mother called 911 and rushed the patient to the hospital. Patient came to and an iv was given in the ambulance to stabilize the patient. Once the patient arrived at the hospital the patient was stable at 160mg/dl and released. No further treatment was given. Additional event or patient information was not provided.
 
Manufacturer Narrative
(b)(4).
 
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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 Key5566066
MDR Text Key42262700
Report Number3004753838-2016-02141
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 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22608-PNK
Device Catalogue NumberSTK-PR-PNK
Device Lot Number5198742
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 Received09/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2015
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: 04/09/2016 Patient Sequence Number: 1
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