BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOND ORACLE HER2 IHC SYSTEM

    MDR report key: 3350421 · Received August 27, 2013

    Report

    Report Number
    3004859032-2013-00001
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Date of Event
    July 29, 2013
    Report Date
    August 2, 2013
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.
    Product Code
    MVC
    PMA / PMN Number
    PA090015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE KIT WAS RETURNED TO LEICA BIOSYSTEMS (B)(4) AND INTERNAL TESTING HAS BEEN CARRIED OUT. THE RETURNED CUSTOMER KIT WAS TESTED AGAINST A RETAINED UNIT OF THE SAME LOT AND ALSO AGAINST THE LOT WHICH THE CUSTOMER IS NOW USING. ALTHOUGH RESULTS FOR LOT 20500 SHOW A DIFFERENCE IN STAINING BETWEEN THE RETAINED AND RETURNED KITS WITH REGARDS TO CELL LINES (WITHIN ACCEPTABLE LIMITS) THE IN HOUSE CONTROL AND TEST SLIDES ARE COMPARABLE. DESPITE THE SLIGHT DIFFERENCE IN CONTROL INTENSITY, THE TEST SECTION CONSISTENTLY SCORES 1+ AND THE OUTCOME FOR THE PT WOULD NOT CHANGE OVER THE 3 KITS TESTED. THEREFORE, THERE WOULD BE NO RISK OF POTENTIAL INJURY TO THE PT USING THE RESULTS OBSERVED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE NEW ORACLE KIT (LOT 20500) WAS STARTED AND THE LAB STAFF FELT THE STAINING ON THE CELL LINE WAS A LITTLE WEAKER THAN NORMAL, BUT ACCEPTABLE, AND THEY CONTINUED TO USE THE KIT. THE FIRST TWO RUNS THEY WERE HAPPY WITH. THE NEXT TWO RUNS WERE REJECTED AS THE CELL LINES WERE STAINING VERY WEAKLY. THE FIRST REJECTED RUN WAS STAINED ON FREDDIE (B)(4). THE CONTROL SLIDE (B)(4) SHOWED SOME VERY WEAK MEMBRANE STAINING IN THE 1+ AND 2+ WAS ALSO WEAK WITH LESS CELLS STAINING THAN EXPECTED. THE IN HOUSE CONTROL WAS OK. ON THE SECOND REJECTED RUN STRAINING ON GEOFFREY (B)(4), THE CONTROL SLIDE (B)(4) STAINING WAS EVEN WEAKER. THE 1 + WAS NEGATIVE FOR MEMBRANE STAINING WITH VERY WEAK BRUSH BORDERS. THE 2+ AND 3+ WERE ALSO VERY WEAKLY STAINED. THE IN HOUSE CONTROL WAS WEAK BUT STILL GAVE 1+, 2+ AND 3+. AT THIS POINT, THE SITE CONTACTED THE LEICA FIELD SUPPORT SCIENTIST AND ALSO OPENED A NEW KIT TO RUN AS A COMPARISON (RUN ON FREDDIE). THIS KIT (LOT 201437) STAINED FINE (CONTROLS (B)(4) STAINED AS EXPECTED). THE CASES FROM THE REJECTED RUNS HAVE BEEN REPEATED WITH THIS NEW KIT. AS A RESULT OF THE OBSERVED STAINING BY THE CUSTOMER, THERE WAS A TWO DAY DELAY IN DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420553 BOND ORACLE HER2 IHC SYSTEM NONE MVC LEICA BIOSYSTEMS NEWCASTLE LTD. TA9145 20500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other