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 and stability were 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 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.
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A low readings issue was reported with the adc device.The customer reported not feeling well for 2 days and the ambulance was called.Upon arriving, a glucose result of 501 mg/dl was obtained on their meter as compared to a sensor scan result of 129 mg/dl.When the results were plotted on the parkes error grid, fell into the 'd' zone showing the difference in values to be clinically significant.The customer was transported to a hospital where they were hospitalized (unknown length) and received unspecified medical treatment for the diagnosis of hyperglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
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