Customer called on (b)(6) 2014 to report a precision issue during testing on (b)(6) 2014.During the phone conversation, the following events were discovered.Patient hospitalized (b)(6) 2014 for 10 days due to stroke.He had used the inratio for 2-5 years but stopped using device and stopped coumadin approx 2-3 weeks before the (b)(6) 2014 stroke.Reportedly, the clt went to the bottom left side of the brain which caused damage to the right eye, some memory loss and difficulty comprehending conversations.After discharge, the patient resumed coumadin and resumed device usage.On (b)(6) 2014, the inratio inr was 2.7.The inr was only checked weekly and therapeutic range was 2.0-2/0.On (b)(6) 2014, patient experienced a headache and went to the emergency room where he was hospitalized for hemorrhagic stroke, lab inr was 4.1 and coumadin was held.Caller reports that there was no additional damage caused by this stroke but patient had vision change due to hemorrhage pressing on nerve.There was no additional intervention, "as body would absorb the blood", per caller.The patient was discharged on (b)(6) 2014 with magnesium supplement prescribed as magnesium was low.On (b)(6) 2014, the caller reported a precision issue.The inratio inr at approx.9 am was 3.8.At approx.9 pm consecutive inratio inrs were 6.5, 4.7, and 5.4.On (b)(6) 2014, the inration was 4.3 caller reported improper technique as multiple drops of blood was applied to the sample well.There was no additional information provided.
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Investigation/conclusion: the precision issue occurring on (b)(6) 2014 may have been due to improper technique as reported by the complainant.This cannot be ruled out as a possible root cause for the unexpected results.It is indicated that 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 repeatability criteria.The products performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and there were no issues related to this complaint.Root cause could not be determined from the information provided by the customer.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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