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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 9500-45
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Dizziness (2194)
Event Date 10/15/2017
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 an adverse event. The sensor was inserted into the upper buttocks on (b)(6) 2017. It was reported that the patient experienced a hypoglycemic event while the continuous glucose monitor (cgm) was displaying "???". It was indicated that the error reading icon was displayed for 6-7 hours. The patient was dizzy and slow, and the patient's mother gave the patient 25ml of glucojuice. At the time of contact, the patient was doing fine. No additional patient or event information is available. No data 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 Key6980903
MDR Text Key90351542
Report Number3004753838-2017-95837
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date08/08/2018
Device Model Number9500-45
Device Catalogue NumberSTS-GF-004
Device Lot Number5228552
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/26/2017 Patient Sequence Number: 1
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