The reported product is not expected to be returned as reporter indicated the device was discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and libre reader, no trends were identified that would indicate any product related issues.Therefore, no further investigations planned.If unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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A delivery issue was reported with the adc device.A customer contacted adc to report an unspecified sensor issue where the device was replaced however, due to a delay in the delivery of the replacement product the customer experienced a medical event.The customer indicated that they had experienced unspecified hypoglycemia symptoms and was unable to self-treat, requiring medical treatment from both a non-healthcare professional and a healthcare professional for the diagnosis of hypoglycemia.The customer did not provide the specifies of the treatment they received as the customer indicated that ¿medical events which are more than a year or 2 years old¿.No further information was reported.There was no report of death or permanent injury associated with this event.
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