Report received of discrepant inratio values.Patient self tester's husband called (b)(6) 2015 with the concern about obtaining qc2h errors on inratio (b)(6) 2015.He provided historical data that led up to the qc2h errors.Per patient self tester's husband: patient discontinued her iron supplement late (b)(6) due to black stools and constipation.Patient has had three previous bouts of anemia/internal bleeding resulting in hospitalizations (details/dates not provided).Patient began warfarin after mitral valve replacement in (b)(6) 2012.Husband is not able to provide any hct values, past or present.Patient's therapeutic range 2.5 - 3.5.(b)(6) 2015 inratio inr = 3.0; later that day patient felt dizzy.(b)(6) 2015 patient fell in the kitchen, she caught her slipper on something and fell.X-rays revealed a hair-line fracture of the foot bone (far-right bone, the bone that the pinkie toe attaches to).Patient was prescribed hydrocodone + acetaminophen for pain.(b)(6) 2015 patient was unsteady/wobbly, blood pressure was low, pulse was 122; husband noticed inside of eyelids were very pale.He brought the patient to the emergency department where her inr lab draw was 4.1.Patient was admitted to the hospital and administered vitamin k.Hospital diagnosis not provided.Subsequent lab draw was an unspecified inr, caller was unsure of subsequent lab draw date or exact result.During hospital stay, patient was administered 2 units of blood, either both units on (b)(6) or one on (b)(6) and one on (b)(6).(b)(6) 2015 patient was discharged from hospital.(b)(6) 2015 patient self tester's husband administered lovenox to patient; then obtained qc2h three times.Brought patient to the lab for venous draw, result was inr 2.5 and other bloodwork was "fine." patient was instructed to discontinue lovenox once inr value reached 2.5, thus no further injections to date based on the lab's test result on (b)(6) 2015.No additional details provided.
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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.A review of in-house testing for the lot revealed no replication of qc errors.The customer's complaint has not been replicated during in-house testing.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.The customer has anemia.This may impact the performance of the assay.The customer had been administered lovenox.This is considered to be off-label use, and cannot be ruled out as a cause for the errors experienced.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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