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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 DEXCOM SHARE SYSTEM MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS Back to Search Results
Model Number MT22495-BLU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 01/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016, to report that she experienced a low event on (b)(6) 2016, resulting in medical intervention. Patient reported that she was wearing dexcom continuous glucose monitor (cgm) at the time of the event. Patient heard the low alarm from her cgm and took 2 glucose tablets. At last check prior to intervention, patient's cgm blood glucose (bg) reading was 55mg/dl and finger stick (fs) bg reading was 37mg/dl. Patient stated that she blacked out. Patient was at a hair solon when events occurred and an employee called paramedics due to the patient losing consciousness during the low event. Patient remembers waking up to an ambulance and her husband at the scene. Patient was given orange juice, but she threw it up. Paramedics/emergency medical technician's (emt) administered 50% dextrose (d50). Patient refused to be taken to the hospital. Patient reported that after intervention, her bg shot up to 301mg/dl around 1:30 pm. Patient took another fs around 2:15 pm, and reported that her bg reading dropped to 210 mg/dl. Patient reported that she takes medications. At the time of contact, the patient reported current condition as "feeling fatigued. " no additional event or patient information is available. There was no alleged device malfunction. It should be noted that diabetes mellitus is a known cause of hypoglycemia, resulting in loss of consciousness.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego 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 Key5404162
MDR Text Key37303170
Report Number3004753838-2016-00852
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
Report Date 01/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMT22495-BLU
Device Catalogue NumberSTK-DR-BLU
Device Lot Number5206582
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 Received01/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2015
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: 02/02/2016 Patient Sequence Number: 1
Treatment
50 MG LOSARTIN (TWICE A DAY)
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