MCKESSON CONSULT 120 URINE ANALYZER

Description of Event or Problem

FALSE NEGATIVE RESULT(S). THE USER REPORTED THAT THEIR ANALYZER GAVE A NEGATIVE LEU RESULT, BUT FURTHER LABORATORY TESTING PRODUCED A POSITIVE LEU RESULT. THIS PATIENT HAD TO BE HOSPITALIZED DUE TO THE NEGATIVE ANALYZER RESULT. THEY SENT THE PATIENT SAMPLE OFF FOR BOTH LABORATORY URINALYSIS AND CULTURE. THE LAB URINALYSIS CAME BACK POSITIVE FOR LEU. THE ANALYZER TEST WAS PERFORMED ON (B)(6) 2026 AND THE SAMPLE WAS SHIPPED OUT FOR FURTHER TESTING THE SAME DAY. STRIPS LOT URS5040001 EXP 5/22/2027. CONFIRMED THEY RUN QC TEST EVERY DAY AND HAVE BEEN PASSING. NO KNOWLEDGE OF ANY INTERFERING SUBSTANCES. PATIENT IS 12 YEARS OLD. THE USER CONFIRMED THAT THE TEST PROCEDURE WAS PERFORMED CORRECTLY. SN WITHIN WARRANTY UNTIL FEBRUARY 2027.