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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 03/10/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced a stroke. At the time of the event, the patient consulted with his endocrinologist who, based on data from the clarity data management tool, dismissed the idea that the stroke was due to the patient's diabetes or his use of the dexcom system. The patient's endocrinologist particularly based this assessment on the provided a1c estimate in clarity. After the event, the patient had an a1c blood lab test performed, and the result, 9. 1, was much higher than the estimated a1c value in clarity, 7. 4. After the blood test, the patient's endocrinologist indicated that the stroke was related to the patient's diabetes, which he believed was not well-controlled due to the a1c estimation given in clarity. At the time of contact, the patient had recovered from the stroke. The patient did not provide any additional event information. A review of clarity data was performed and the estimated a1c was 8. 2. The reported event of stroke due to diabetes was not confirmed. A root cause could not be determined. Dexcom labeling indicates: caution- the [clarity] software does not provide any medical advice and should not be used for that purpose. Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software.
 
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Brand NameDEXCOM G5 MOBILE 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 Key6474275
MDR Text Key72172470
Report Number3004753838-2017-26270
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 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2017
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 Received03/10/2017
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: 04/07/2017 Patient Sequence Number: 1
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