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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 MT20649-2
Device Problem Defective Alarm (1014)
Patient Problems Hypoglycemia (1912); Dizziness (2194)
Event Date 10/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, an intermittent audio output and a hypoglycemic event was reported. The patient stated during the night, they did not feel well. They felt light headed and their legs were wobbly. They tested their blood sugar with a blood glucose meter and it was reading 2. 8mmol/l. The patient treated themselves by eating fruit pastilles and their hypoglycemic symptoms went away. Additionally, the patient stated after they recovered from the hypoglycemic event, they checked the continuous glucose monitor (cgm) and it was displaying 3. 5mmol/l and they noticed that they were not alerted. It was indicated that the patient's low alert setting was at 4. 5mmol/l in which they should have been alerted of the low value. At the time of contact, the patient was in stable condition. No additional patient or event information is available. No product or data was provided for investigation. Confirmation of the complaint was undetermined. The root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint receiver device was returned for evaluation. The device was visually inspected and no defects were found. The receiver was charged and rebooted. A functional test was performed and it passed. The receiver log was downloaded and evaluated with no related errors observed. A communication tool audio test was performed and the tests passed. "try it" manual tests were performed and the tests passed. Speaker audio intermittent tests were performed and the tests passed. The speaker resistance was measured and it registered within specification. The reported event of intermittent audio output was not confirmed. The 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 Key8075531
MDR Text Key127295710
Report Number3004753838-2018-142549
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,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-109
Device Lot Number5234974
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2017
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: 11/15/2018 Patient Sequence Number: 1
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