BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA BOND-MAX

    MDR report key: 2192747 · Received June 16, 2011

    Report

    Report Number
    8020030-2011-00036
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS WERE EVALUATED AS PART OF THE INVESTIGATION OF THIS COMPLAINT. ON-SITE ASSESSMENT OF THE OPERATION AND FUNCTION OF THE INSTRUMENT WAS CONDUCTED BY A LEICA FIELD SERVICE ENGINEER (FSE) ON (B)(4) 2011. THE FSE DETERMINED THAT THE CALIBRATION OF THE ROBOT HAD ALTERED MID-RUN, RESULTING IN MISALIGNMENT OF THE ASPIRATING PROBE. EVAL OF THE INSTRUMENT LOGS CONDUCTED BY GLOBAL TECHNICAL SUPPORT FOUND THAT: THE PROTOCOL CONTAINING THE ORACLE HER2 BOND IHC SLIDES WHICH DID NOT STAIN, RAN TO COMPLETION. THE LOGS DO NOT INDICATE THAT THE ASPIRATION PROBE CONTACTED ANY COMPONENT. AN ERROR CODE RECORDED IN THE INSTRUMENT SOFTWARE INDICATES DETECTION OF INCONSISTENT REAGENT LEVELS RESULTING IN REAGENT BEING ASPIRATED FROM THE BOTTOM OF THE REAGENT CONTAINER(S), WHICH IS NORMAL INSTRUMENT FUNCTION IN THIS CIRCUMSTANCE. AN ERROR CODE INDICATING AN LLS WHICH IS READING ABOVE THE REAGENT LINE, IS ALSO RECORDED IN THE INSTRUMENT SOFTWARE. INVESTIGATION OF THIS COMPLAINT DETERMINED THAT THE ROOT CAUSE FOR THE FAILURE TO STAIN THE ORACLE HER2 BOND IHC SLIDES IN THE AFFECTED RUN WAS MISALIGNMENT OF THE ASPIRATION PROBE IN CONJUNCTION WITH AN LLS ERROR. MISALIGNMENT OF THE ASPIRATION PROBE MAY BE CAUSED BY THE ROBOT ARM BEING ACCIDENTALLY MOVED, THE ASPIRATION PROBE NOT BEING FITTED CORRECTLY OR A COVERTILE NOT BEING POSITIONED CORRECTLY. THE LLS ERROR MAY RESULT FROM A LOOSE OR INCOMPLETE CONNECTION OR THE LLS NOT FUNCTIONING CORRECTLY.

    Description of Event or Problem · 1

    ON (B)(6), 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) REGARDING STAINING FAILURE FOR A STAINING RUN(S) CONTAINING ORACLE HER2 BOND IHC SLIDES, USING BOND-MAX AUTOMATED SLIDE STAINER (B)(4). ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED INFO THAT SUFFICIENT PT SAMPLE WAS AVAILABLE TO PREPARE SLIDES FOR REPEAT STAINING, PT RE-BIOPSY WAS NOT REQUIRED AND THERE WAS NO DELAY IN PT DIAGNOSIS AS A CONSEQUENCE OF THE INSTRUMENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA BOND-MAX AUTOMATED SLIDE STAINER IEO LEICA BIOSYSTEMS MELBOURNE BOND-MAX

    Patients

    Seq Age Sex Outcome Treatment
    1