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 sensor and sensor kit were reviewed, and the dhrs showed the 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.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Adc received a complaint via webform about issues with the adc device.Adc customer service contacted the customer and the caregiver reported that upon inserting the sensor, the customer experienced ¿intense bleeding¿, bruising at the inserting site, and their glucose level dropped resulting in a symptom of dizziness.The customer was treated with sugar and juice by a family.The healthcare professional was then called and the customer was provided unspecified cream to calm the bruising.No further information was provided.There was no report of death or permanent injury associated with this event.
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