BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL IVIEW DAB

    MDR report key: 914302 · Received March 13, 2007

    Report

    Report Number
    2028492-2007-00007
    Event Type
    Malfunction
    Date Received
    March 13, 2007
    Date of Event
    January 24, 2007
    Report Date
    January 24, 2007
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    NJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER LOTS LISTED IN THE TREND ARE LOT NUMBER 513540 (EXPIRATION DATE OF 2007/12/31) AND LOT NUMBER 515248 (EXPIRATION DATE OF 2007/12/31) FOR PRODUCT NAME IVIEW DAB DETECTION. THE FIRM WILL ISSUE A CUSTOMER COMMUNICATION TO ALERT THEM OF THE PARTICULATES AND REMIND CUSTOMERS OF THE INSPECTION PRACTICES DEFINED IN THE PACKAGE INSERT. DUE TO THE REMOTE POSSIBILITY OF AN ERRONEOUS BUT BELIEVABLE RESULT THE LETTER WILL ASK THE CUSTOMER TO LOOK FOR ANY PARTICULATES IN THE LISTED LOTS OF IVIEW DAB PRODUCTS AND HAVE THEM RETURN ANY DISPENSERS THAT APPEAR SUSPECT. THE FIRM IS ALSO TAKING CORRECTIVE AND PREVENTIVE ACTION BY REPLACING THE SULFUR CURED O-RING WITH A PEROXIDE CURED O-RING WHICH WILL HELP PREVENT FUTURE OCCURRENCES. THE FIRM WILL ALSO DISTRIBUTE A WHITE PAPER THAT DESCRIBES OPTIMAL LAB PRACTICES. THIS PAPER REFERENCES THE COLLEGE OF AMERICAN PATHOLOGISTS ANATOMIC PATHOLOGY CHECKLIST ITEM ANP .22550 WHICH STATES " A POSITIVE CONTROL SECTION INCLUDED ON THE SAME SLIDE AS THE PATIENT TISSUE IS OPTIMAL PRACTICE BECAUSE IT HELPS IDENTIFY FAILURE TO APPLY PRIMARY ANTIBODY OR OTHER CRITICAL REAGENTS TO THE PATIENT TEST SLIDE.

    Description of Event or Problem · 1

    A TREND IN CUSTOMER COMPLAINTS REVEALED THAT THE VOLUME OF DAB COMPONENT WAS NOT DISPENSING AT THE SAME LEVELS AS OTHER REAGENTS. PATIENT CARE WAS NOT AFFECTED. OF THE RETURNED KITS EXAMINED THERE WAS A VERY LOW RATE OF PARTICULATES OBSERVED IN THE DAB (CHROMOGEN) COMPONENT. IN A SMALL NUMBER OF CASES THE PARTICULATE COULD OCCLUDE THE OPENING AND RESULT IN INCONSISTENT STAINING. ALTHOUGH NONE HAVE BEEN REPORTED THERE IS A POSSIBILITY FOR A FALSE NEGATIVE IF THE DISPENSER IS COMPLETELY OCCLUDED OR PARTIALLY OCCLUDED CAUSING INCONSISTENT STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL IVIEW DAB NJT NJT VENTANA MEDICAL SYSTEMS, INC. NA 512384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA