D
Patient 1
THIS EVENT OCCURRED IN ANOTHER COUNTRY WHERE THE ALBUSTIX PRODUCT IS DISTRIBUTED FOR PROFESSIONAL USE ONLY. IN THIS REPORTED INCIDENT, A BOTTLE OF ALBUSTIX, WHICH IS A URINE STRIP PRODUCT THAT MEASURES PROTEIN, WAS GIVEN TO THE PARENTS OF A CHILD WITH KIDNEY DISEASE, UNDER THE DIRECTION OF THE DR, SO THEY COULD MONITOR THE CHILD'S PROTEIN LEVEL AT HOME. THE PARENTS WERE PROVIDED DIRECTIONS ON HOW TO USE THE ALBUSTIX BY THE DR AND WERE TOLD THAT IF THE ALBUSTIX RESULTS WERE POSITIVE THREE TIMES CONTINUOUSLY, THE CHILD SHOULD BE BROUGHT BACK TO THE HOSP. WHEN THE PARENTS TESTED THE CHILD, THE RESULTS SHOWED A BLUE-GREEN COLOR, WHICH ON THE ALBUSTIX COLOR CHART IS INDICATIVE OF AN ELEVATED PROTEIN LEVEL. HOWEVER, WHEN THE PARENTS COMPARED THE TEST STRIP TO THE COLOR CODE ON THE BOTTLE LABEL, THIS BLUE-GREEN COLOR MATCHED A NEGATIVE RESULT. BECAUSE THE CHILD TIRED EASILY AND HIS FACE WAS SWOLLEN, THE PARENTS THOUGHT SOME THING WAS WRONG AND DISCOVERED THAT THE BOTTLE LABEL WAS INCORRECT. THEY TOOK THE CHILD TO THE HOSP AND HIS PROTEIN TESTED AT A LEVEL OF 3+, WHICH CORRESPONDS TO AN ELEVATED PROTEIN LEVEL AND IS BLUE-GREEN ON THE ALBUSTIX COLOR CHART. IT WAS FOUND THAT THE SPECIFIC BOTTLE OF ALBUSTIX THAT WAS GIVEN TO THE PARENTS, HAD A GLUCOSE URINE STRIP PRODUCT LABEL, NOT AN ALBUSTIX LABEL. THE COLOR CODING ON THE GLUCOSE BOTTLE LABEL FOR A NEGATIVE GLUCOSE IS THE SAME BLUE-GREEN COLOR AS AN ELEVATED PROTEIN LEVEL FOR THE ALBUSTIX PRODUCT. WHEN THE PARENTS COMPARED THE CHILD'S ALBUSTIX TEST RESULTS TO THE COLOR CODE ON THE BOTTLE LABEL, THEY INTERPRETED THE TEST RESULTS AS NEGATIVE WHEN IT WAS ACTUALLY AN ELEVATED PROTEIN LEVEL.