Dexcom was made aware on 01/23/2017, that on (b)(6) 2016, the patient did not hear the fixed low alert on her receiver, in addition to an adverse event that occurred.The patient stated that she woke up in middle of the night on (b)(6) 2016 and wasn't feeling good.The patient went to bathroom then back to bed and stated she did not hear her dexcom alarms.The patient states that she woke up and found her bedside table shattered and she had pain in her head and hand.The patient could not remember what had happened during the night and believes it was a low blood glucose event.The patient considered pain in hand was from rheumatoid arthritis and the patient did not seek medical attention at that time and self-medicated.On (b)(6) 2016, the patient drove herself to the emergency room (er) due to continued pain in her hand and er doctor diagnosed a broken scaffold due to event and being hypoglycemic unaware.The patient also went to orthopedic doctor on (b)(6) 2016 as follow up, regarding broken hand for adverse event on (b)(6) 2016.The doctor stated the patient may require surgery.There is no reported surgery as of yet.At time of contact the patient has a cast on her hand and is in stable condition.No additional event or patient information is available.The device has been received for evaluation.A follow-up report will be submitted once the evaluation is complete.
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