A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer experienced a loss of consciousness, a seizure, and a dislocated shoulder ; however, after symptoms subsided the customer was seen by a hcp who reset the customer's shoulder.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.
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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 reader were reviewed, and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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