Caller alleging discrepant inratio value.(b)(6) 2015 inratio 1.2; lab 2.2 time between tests two hours.Patient's therapeutic range 2-3 on (b)(6) 2015 the patient was sent to the emergency room for shortness of breath and to rule out a pulmonary embolism after obtaining 1.2 inr on the inratio.When the hospital lab inr of 2.2 was received, the patient was not admitted to the hospital and was discharged from the emergency room.Caller stated no treatment was provided to the patient, because the inr was within the therapeutic range.No admitting or discharge diagnoses was provided.Although requested, no additional information has been received.
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Investigation conclusion: it is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.Retain strip testing results met both accuracy and strip repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any relevant non-conformances.The lot meets release specification.Root cause is unable to be determined from the information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
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