Dexcom was made aware on 09/09/2016, that on (b)(6) 2016, the patient went to the hospital for acute pneumonia.The patient reported the event while inquiring about general information regarding the device.Additionally, it was indicated that the acute pneumonia was caused by the patient's diabetes.At the time of the event, the patient was wearing the dexcom continuous glucose monitor (cgm) however, there was no alleged device malfunction.At the time of contact, the patient was in normal condition.No additional event or patient information is available.No product or data was returned for evaluation.The reported event of acute pneumonia due to diabetes could not be confirmed.A root cause could not be determined.
|