A customer reported a high reading issue with the freestyle libre 2 sensor.The customer reported unspecified high sensor reading, as compared to an unspecified capillary meter.The customer subsequently became hypoglycemic and experienced disorientation, severe sweating, increased body temperature, palpitations, and a loss of consciousness.Paramedics were called and a healthcare meter result of 3.2 mmol/l was obtained.The customer was treated with glucose injection, given liquids to drink, and was monitored until stable.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 there was no indication that the product did not meet specification.Dhrs (device history record) for the freestyle libre sensor and freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle 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.All pertinent information available to abbott diabetes care has been submitted.
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