BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSITE HER-2/NEU

    MDR report key: 679505 · Received February 15, 2006

    Report

    Report Number
    2936532-2006-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2006
    Report Date
    February 14, 2006
    Manufacturer
    BIOGENEX LABORATORIES, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RAISED BY ONE OF CO'S EMPLOYEES, WHILE DEMONSTRATING AN INVITRO DIAGNOSTIC (IVD) TEST FOR HER-2/NEU AT TWO CUSTOMER SITES. THE COMPLAINT REPORTED THE OBSERVATION OF GRANULAR AND LINEAR STAINING OF BREAST CANCER TISSUE SECITONS THAT WERE IMMUNOSTAINED WITH THE BIOGENEX INSITE HER-2/NEU TEST. THE CONTROL SLIDES WERE ALSO ALLEGED TO SHOW SIMILAR STAINING PATTERNS. ALTHOUGH LINEAR STAINING IS NORMAL, GRANULAR STAINING MAY LEAD TO MISDIAGNOSIS DUE TO A FALSE POSITIVE RESULT. SUBSEQUENT PRELIMINARY IN-HOUSE TEST TO ADDRESS THIS COMPLAINT HAD FAILED TO REPRODUCE THIS STAINING PATTERN. HOWEVER, WHILE INVESTIGATING THIS MATTER, USER FACILITY DISCOVERED THAT PROCEDURES WERE NOT FOLLOWED IN THE MANUFACTURING PROCESS FOR THIS IVD DEVICE. AS OF FEBRUARY 2006, THE COMPANY HAD INITIATED A VOLUNTARY PRODUCT RECALL (VIA A REMOVAL) AND ALSO CARRIED OUT A STOCK RECOVERY, AS WELL AS CEASED FURTHER DISTRIBUTION AND MANUFACTURE OF THIS DEVICE, IN THE INTEREST OF ENSURING PATIENT SAFETY AND WELFARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSITE HER-2/NEU ANTIBODY TEST KIT FOR HER-2/NEU KPA BIOGENEX LABORATORIES, INC. * A11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA