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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A customer reported that a sensor error message was received with the adc device and as a result, the customer was unable to obtain glucose readings.The customer became hypoglycemic and experienced a loss of consciousness which led to a fall that resulted in a broken left leg.The customer was rushed to a hospital where a glucose result of 40 mg/dl was obtained on the hcp meter and an x-ray was performed on the leg.The customer was administered intravenous glucose for the diagnosis of hypoglycemia.In addition, the customer was also provided ¿novorapid, tresiba, amlodipine tablets 5mg, olmesartan od tablets 20mg, rebamipind 100, loxoprofen tablets 60mg¿ for treatment.There was no report of death or permanent injury associated with this event.
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