D
Patient 1
THE CUSTOMER RECEIVED A QUESTIONABLE PHENYTOIN RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT OF 2.9 UG/ML WAS FROM AN ALIQUOT OF A "RED TOP TUBE" PROCESSED BY A CLIENT OF THE CUSTOMER. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE PATIENT WAS RETESTED AT THE HOSPITAL WITH A RESULT OF 21.9 UG/ML. AN SST SAMPLE THAT WAS DRAWN AT THE SAME TIME AS THE ORIGINAL "RED TOP TUBE" WAS TESTED AND THE RESULTS WERE 18.7 UG/ML AND 18.8 UG/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER COULD NOT PROVIDE DETAILS CONCERNING IF THE PATIENT WAS ADVERSELY AFFECTED. THE PHENYTOIN REAGENT LOT NUMBER WAS 67251701 WITH AN EXPIRATION DATE OF 03/31/2014. THE FIELD SERVICE REPRESENTATIVE NOTED THE ORIGINAL POUR OFF TUBE WAS EMPTY AND DISCARDED SO IT COULD NOT BE CHECKED FOR ISSUES. HE CHECKED THE SYSTEM FUNCTIONS FOR RINSE, REAGENT AND SAMPLE DISPENSE WHICH WERE VERIFIED. HE CHECKED CALIBRATION AND QC AND RAN PRECISION WITH ALL RESULTS IN RANGE.