BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUTROPHIL SLIDE

    MDR report key: 174132 · Received June 26, 1998

    Report

    Report Number
    2026994-1998-00001
    Event Type
    Death
    Date Received
    June 26, 1998
    Date of Event
    April 1, 1998
    Report Date
    June 25, 1998
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Product Code
    MOB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUTROPHIL SLIDE ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY SLIDES MOB INOVA DIAGNOSTICS, INC. NA 722939

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR