Dexcom was made aware on 12/26/2016 that on (b)(6) 2016, the patient experienced no audio alert and an adverse event.Patient reported that he took the wrong insulin and his blood glucose (bg) went to 22 mg/dl.His spouse called paramedics due to his symptoms that included screaming, yelling, and cold sweat.Patient was treated with "some kind of goop." patient does not know the name of the goop or who treated him.Patient did not want to go to hospital.Patient stated that his continuous glucose monitor (cgm) did not give an audible alert.Additionally, the patient tested the receiver's alerts and they worked.No further event or patient information is available.At the time of contact, patient is doing well.No additional event or patient information is available.The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and the reported fault could not be reproduced and there was no failure detected.A review of the downloaded receiver log did not find any errors related to the customer complaint.A "try it" manual test was performed and was able to verify that the speaker beeped and it passed.A manual drop test for intermittency was performed and the test passed.The receiver case was opened for further evaluation.A visual interior inspection was performed and the inspection passed.The device was determined to be operating within the required specifications without malfunction.The reported event of an intermittent audio output was not confirmed.A root cause could not be determined.
|