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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 Problems Defective Alarm (1014); No Audible Alarm (1019)
Patient Problem Hypoglycemia (1912)
Event Date 08/14/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The field entry does not represent the date of birth of the patient and should be read as ¿no information. ¿.
 
Event Description
It was reported that the patient experienced no audio output and an adverse event. The patient reported that the receiver did not alert when the patient was in hypoglycemia. No symptoms were reported and no glucose values levels were provided. There was no documentation of medical intervention. No data or product was provided for investigation. Confirmation of the allegation was undetermined. The root cause could not be determined. No additional patient or event information is available. This is being reported due to the vague report of a hypoglycemic event.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced intermittent audio output and an adverse event.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ying chen
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key9176259
MDR Text Key161917150
Report Number3004753838-2019-071988
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 distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-1
Device Catalogue NumberSTR-GL-004
Device Lot Number5253446
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? No
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: 10/10/2019 Patient Sequence Number: 1
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