At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.The device mfg date 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.
|
A caregiver reported on behalf of her son who received low readings from the adc freestyle libre 2 sensor as compared to the built-in meter.The customer experienced symptoms of nasuea, vomiting, thirst, paleness, dizziness, and was unable to self-treat.The customer was taken to the hospital where he was diagnosed with hyperglycemia and treated with insulin (dose/type unknown).There was no report of death or permanent injury associated with this event.
|