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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