BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA BIOSYSTEMS

    MDR report key: 5249572 · Received November 18, 2015

    Report

    Report Number
    3004859032-2015-00003
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 30, 2015
    Report Date
    November 18, 2015
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.
    Product Code
    MYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAVE CONFIRMED THEY HAVE DESTROYED THE UNIT THEREFORE, FURTHER TESTING COULD NOT BE PERFORMED. THE RETAINED UNIT HAD BEEN TESTED ACCORDING TO THE IFU/DMR, NO ISSUES WERE OBSERVED WHEN TESTING WITH KNOWN POSITIVE CONTROL SAMPLES, BOTH TISSUE AND CELL LINES (CELL LINES ARE PROVIDED WITH THE ORACLE KIT). .

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS TO BE RETURNED TO LEICA BIOSYSTEMS NEWCASTLE LTD TO PERFORM TESTING. THE RETAINED UNIT HAS BEEN TESTED ACCORDING TO THE IFU/DMR, NO ISSUES WERE OBSERVED WHEN TESTING W/KNOWN POSITIVE CONTROL SAMPLES, BOTH TISSUE AND CELL LINES (CELL LINES ARE PROVIDED WITH THE ORACLE KIT). NO FURTHER ACTIONS AT THIS TIME UNTIL THE CUSTOMER UNIT HAS BEEN RETURNED FOR TESTING.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS (B)(4) RECEIVED A COMPLAINT TO STATE BOND ORACLE HER2 IHC SYSTEM TA9145 BATCH 30140 TO STATE THE FOLLOWING: "THERE IS A LOT MORE BACKGROUND STAINING THAN USUAL AND NOT AS CRISP AS IT USED TO BE. ALSO, THE MEMBRANOUS "CHICKEN WIRE STAINING IS NOT CONTINUOUS, IT APPEARS BROKEN UP". THIS RESULTED IN THE RE BIOPSY OF 3 PATIENTS. THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762347 LEICA BIOSYSTEMS BOND ORACLE HER2 IHC SYSTEM MYA LEICA BIOSYSTEMS NEWCASTLE LTD. 30140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other