Investigation conclusion: it is indicated that the product is not returning for evaluation.As the patient did not provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
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The patient began using the inratio system in approximately 2012 and tested on a weekly or bi-weekly basis.On or around (b)(6) 2016, the patient experienced anemia and internal bleeding and was subsequently administered a blood transfusion.The patient alleges the inratio system produced significantly inaccurate inr results which prevented medical providers from prescribing a safe and effective dose of coumadin in a timely manner, resulting in the reported injuries.
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