Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, the patient experienced no audio alert from the receiver and an adverse event.Patient's mother reported that patient experienced a seizure in her kitchen due to the audio alert not sounding.The patient's mother called 911.Patient was taken to the emergency room (er).Patient's mother reported patient having blood work and a computerized tomography (ct) scan, but no treatment was given.No additional event or patient information is available.No product was provided for evaluation.Data was received for evaluation.However, an evaluation cannot be performed to confirm the reported issue.A root cause could not be determined.The sensor was inserted into the arm.The dexcom g5 mobile continuous glucose monitoring system states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.
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