Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the receiver displayed a firmware error.There was no report of injury or medical intervention.No additional patient or event information is available.It was reported that a pediatric patient was using a receiver approved only for adults.It should be noted that the dexcom g4® platinum continuous glucose monitoring system states: the dexcom g4 system is not approved for use in children or adolescents, pregnant women or persons on dialysis.However, a root cause for the reported firmware error cannot be determined.It was reported that a pediatric patient was using a receiver approved only for adults.It should be noted that the dexcom g4® platinum continuous glucose monitoring system states: the dexcom g4 system is not approved for use in children or adolescents, pregnant women or persons on dialysis.The device has been received for evaluation.A follow-up report will be submitted once the evaluation is complete.
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