At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.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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A customer reported a "bent needle in the applicator" with the adc device.As a result, customer experienced symptoms described as "was sleeping, and shaken, agitated, sweat" a loss of consciousness and was unable to self-treat.Customer required third-party intervention by wife who provided subcutaneous glucagon as treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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