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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 Bruise/Contusion (1754); Hypoglycemia (1912); Seizures (2063)
Event Date 05/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that the patient experienced a hyperglycemic event on (b)(6) 2016 at 2:00 am. Patient stated that her service dog woke her up. Patient stated that she had a seizure and hit her head on her night stand when trying to stand up. Patient stated that her family drove her to the hospital which took 45 minutes to an hour. Patient stated that she was given an iv containing intravenous sugar solution. Patient stated that her blood glucose (bg) was at 35mg/dl when arriving at the hospital. Patient stated that she was released from the hospital in the early morning between 8:00-9:00 am. Patient reported that she had bruising on the side of her head, but experienced no further injuries. Patient stated that she was not using the continuous glucose monitor (cgm) at the time of the hypoglycemic event due to a shipping error with a replacement transmitter. At the time of contact, patient is healthy. No additional patient or event information was provided.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that the patient experienced a hypoglycemic event on (b)(6) 2016 at 2:00 am. Patient stated that her service dog woke her up. Patient stated that she had a seizure and hit her head on her night stand when trying to stand up. Patient stated that her family drove her to the hospital which took 45 minutes to an hour. Patient stated that she was given an iv containing intravenous sugar solution. Patient stated that her blood glucose (bg) was at 35mg/dl when arriving at the hospital. Patient stated that she was released from the hospital in the early morning between 8:00-9:00 am. Patient reported that she had bruising on the side of her head, but experienced no further injuries. Patient stated that she was not using the continuous glucose monitor (cgm) at the time of the hypoglycemic event due to a shipping error with a replacement transmitter. At the time of contact, patient is healthy. No additional patient or event information was provided.
 
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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
8585000200
MDR Report Key5757065
MDR Text Key48398396
Report Number3004753838-2016-03629
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,Followup
Report Date 06/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2016
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: 06/28/2016 Patient Sequence Number: 1
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