Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver displayed "err hw".No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of the error icon could not be determined.A probable cause could not be determined.Additionally, it was reported that continuous glucose monitoring (cgm) device is being used on a patient under 2 years of age. labeling indicates: the dexcom continuous glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. however, a probable cause for the reported inaccuracy cannot be determined.
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