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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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-1
Device Problem No Audible Alarm (1019)
Patient Problems Fainting (1847); Hypoglycemia (1912); Seizures (2063)
Event Date 08/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced no audio output and a hypoglycemic event. It was reported that the continuous glucose monitor (cgm) did not give audio output for the low alert and the patient fell into severe hypoglycemia. It was indicated that the patient had fainted and had seizures but shortly before they fainted, they had drunk a cola. The ambulance was called and when the emergency doctor arrived, a blood glucose value of 60 mg/dl was measured. At the time of the patient's low event, the cgm value was unknown. The doctor administered the patient with intravenous (iv) glucose therapy. At the time of contact, the patient was feeling fine again. No additional patient or event information is available. No product was provided for evaluation. The reported event could not be confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
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 Key6841897
MDR Text Key84666412
Report Number3004753838-2017-55991
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 08/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5219224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2016
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: 09/05/2017 Patient Sequence Number: 1
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