Caller alleging receiving a discrepant low inratio value.On (b)(6) 2014 no inratio value was reported only that the value was within the patient's therapeutic range.On (b)(6) 2014, no exact lab value reported only that the lab was greater than 4 inr difference.Time between tests two days.Patient's therapeutic range unk (not provided).Caller stated patient had clinical symptoms of bruising and nose bleeds.No additional information provided.Although multiple attempts were made to obtain follow-up treatment and additional patient information, they were unsuccessful.No additional information available.
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The customer did not provide a lot number or return any products for investigation.Unable to perform further investigation w/o additional information.Since the product associated with the complaint was not returned, manufacturing record review could not be performed and further investigation was not possible.As there is no indication of a product deficiency, no corrective action is required at this time.
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