This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite international instrument, serial number (b)(4).Accriva diagnostics' complaint numbers (b)(4) capture child complaints against two elite international instruments, serial numbers (b)(4), respectively.Accriva diagnostics' complaint numbers (b)(4) capture the two hemochron act+ reagent cuvettes, lot numbers g8jac307 and g8jac333, respectively, that were used during the procedure.This mdr serves as the initial report of the device malfunction.Once an evaluation of the instruments and reagent is completed, follow-"ip" mdr #1 will be submitted.
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