NEUTROPHIL SLIDE

Description of Event or Problem

THE CUSTOMER IN FRANCE PURCHASED SOME COMPONENTS OF THE NOVA LITE ANCA(ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY) KIT FROM A FRENCH DISTRIBUTOR. THE COMPONENET THAT MAKE UP THE KIT ARE PBS CONCENTRATE, MOUNTING MEDIA, "CANCA" POSITIVE, "PANCA" POSITIVE, CONJUGATE, NEGATIVE CONTROL AND ETHANOL-FIXED NEUTROPHIL SLIDES. THE CUSTOMER PURCHASED AND USED THE FOLLOWING COMPONENTS OF INOVA'S DEVICE TO PERFORM THE TEST: NEUTROPHIL SLIDES,LOT NUMBER 722939; AND FITC-IGG CONJUGATE, LOT 722737. THESE COMPONENTS WERE USED WITH OTHER COMPONENTS THAT ARE NOT MANUFACTURED BY INOVA SUCH AS PBS. THE PBS SOLUTION REQUIRED TO PERFORM THE TEST WAS PREPARED BY THE CUSTOMER'S LAB. THE PATIENT WENT TO THE RHEUMATOLOGIST. THE RHEUMATOLOGIST SUSPECTED WEGENER'S GRANULOMATOSIS IS BASED ON CLINICAL SYMPTOMS AND REQUESTED "ANCA" TEST. THE TECHNICIAN REQUESTED THE PATIENT SAMPLE USING THE NEUTROPHIL SLIDES ON MARCH 30,1998 AND INTERPRETED THE RESULT AS NEGATIVE. THE BIOLOGIST RAN IT ON A DIFFERENT DAY AND INTERPRETED IT AS A WEAK POSITIVE. THE PATIENT WAS SENT TO NEPHROLOGY. THE CLINICAIN REQUESTED AN "ANCA" TEST. THE TEST WAS PERFORMED USING "BMD" AND BIOADVANCED "ANCA" ETHANOL SLIDES AND THE RESULTS WERE INTERPRETED AS POSITIVE "ANAC." THE PATIENT WAS PUT ON CORTICOTHERAPY. THE PATIENT DIED IN APRIL 1998. POST MORTEM BIOPSY CONFIRMED WEGENER'S GRANULIMATOSIS DISEASE AND CRESENTIC NEPHRITIS GLOMERULONEPHRITIS.