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 it has been determined that 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.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.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 caller reported that a sensor error message was received on the adc device.As a result, the customer was unable to monitor their blood glucose, however, had self-treated with rapid insulin (dose unknown).Consequently, the customer experienced palpitations, nausea, and a loss of consciousness.It was further reported that the customer was able to self-treat with coconut and 2 bags of sugar and no further information was reported.There was no report of death or permanent injury associated with this event.
|