BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCA SLIDE

    MDR report key: 285488 · Received July 13, 2000

    Report

    Report Number
    2026994-2000-00001
    Event Type
    Injury
    Date Received
    July 13, 2000
    Date of Event
    January 1, 2000
    Report Date
    July 13, 2000
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Product Code
    MOB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTICA, INOVA DIAGNOSTICS, INC.'S AUSTRIAN DISTRIBUTOR, REPORTED THAT ONE OF THEIR CUSTOMERS INDICATED THAT THE FORMALIN FIXED, 12-WELL NEUTROPHIL SLIDES, (PART NUMBER 508297, LOT NUMBER 922515) ARE TOO SENSITIVE. A PT PRESENTED SYMPTOMS OF PULMO-RENAL INSUFFICIENCY AND WAS BEING SEEN IN NEPHROLOGY. THE NEPHROLOGIST SENT THE PT SAMPLE TO THE LAB. A TEMPORARY TECH RAN THE PT SAMPLE ON THE ANCA TEST USING BOTH THE FORMALIN FIXED SLIDES(508297, 922515) AND THE ETHANOL FIXED SLIDES(508296, 022268). THE TECH USED THE PBS SOLUTION PREPARED BY THEIR LAB AND NOT THE PBS SOLUTION MFG BY INOVA DIAGNOSTICS REQUIRED FOR THE ANCA TEST. THE TECH READ THE FORMALIN FIXED SLIDES AS POSITIVE AND THE ETHANOL FIXED SLIDES AS NEGATIVE. THE INITIAL RESULT REPORTED FROM THE TEST LAB IN AUSTRIA WAS ANCA POSITIVE. THE PT WAS IMMEDIATELY TREATED WITH ENDOXAN BASED ON THIS PRELIMINARY RESULT. FURTHER TESTS PERFORMED THE FOLLOWING DAY ON THE ETHANOL FIXED SLIDE FROM INOVA AND THE PR3 AND MPO ELISA TESTS FROM WIESLAB INDICATED NEGATIVE RESULTS. THE AUSTRIAN DISTRIBUTOR INDICATED IN HER FAX TO INOVA THAT "THE PT WILL PROBABLY NOT SURVIVE THE WEEK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCA SLIDE FORMALIN FIXED HUMAN NEUTROPHIL SLIDE MOB INOVA DIAGNOSTICS, INC. NA 922515

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening