The customer's meter was received for investigation.The customer's meter was tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.3 inr, donor 2 inr: 2.3 inr.Donor 1 hct: 35%, donor 2 hct: 36%.Testing results: donor 1: retention meter with master lot strips: 2.3 inr, customer meter with master lot strips: 2.3 inr.Donor 2: retention meter with master lot strips: 2.3 inr, customer meter with master lot strips: 2.3 inr.Results: all inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.All alleged results by the customer were observed in the meter¿s patient result memory (attached to the case).-customer received an error 5.This means not enough blood was applied to the strip.According to the product labeling not applying enough blood to the strip will result in an error 5.No information was provided in the complaint case that would point to a cause for the result discrepancy.
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