A customer reported that a sensor error message was received with the adc device.As a result, the customer experienced symptoms of blurred vision, tachycardia, and sweating however, the customer was able to self-treat with 1 liter of juice.The customer was then seen at a hospital and was provided glucose serum and 12 units of rapid insulin for treatment.No further information was reported.There was no report of death or permanent injury 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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits 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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