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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urinary Tract Infection (2120); Virus (2136); Loss of consciousness (2418)
Event Date 05/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of unconsciousness.
 
Event Description
Patient's brother contacted dexcom on (b)(6) 2016 to report that the patient had an adverse event on (b)(6) 2016. Patient's brother stated patient had collapsed at home. The patient's brother tried reaching the patient over the phone and called 911 after receiving no answer. The patient's brother was unable to confirm whether patient was still unconscious once paramedics arrived or how she was treated since he was not provided a complete report by the hospital. The patient's brother mentioned a virus and urinary tract infection (uti) that may have been the cause for the patient going unconscious. At time of contact, the patient was still under the care of the hospital and undergoing rehabilitation. There was no alleged device malfunction. No additional event or patient information is available.
 
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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 Key5745843
MDR Text Key48063534
Report Number3004753838-2016-03520
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 05/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received05/25/2016
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

Patient Treatment Data
Date Received: 06/23/2016 Patient Sequence Number: 1
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