At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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A caregiver reported bleeding upon adc device insertion.The caregiver reported that due to the bleeding, in addition to pain and bruise upon insertion, the sensor was removed and the customer subsequently was unaware when hypoglycemic with tremors.The customer was treated with sugar and juice.There was no report of death or permanent injury associated with this event.
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