BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOND ORACLE HER2 IHC SYSTEM

    MDR report key: 5440961 · Received February 10, 2016

    Report

    Report Number
    3004859032-2016-00002
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    September 14, 2015
    Report Date
    January 23, 2016
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.
    Product Code
    MVC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RESULTS AND FURTHER TESTING BY THE HEALTHCARE PROFESSIONAL DEMONSTRATED 3 PTS SAMPLES MAY HAVE GIVEN A FALSE NEGATIVE RESULT. ON 23RD JANUARY 2016, (B)(4) WERE GIVEN THE FOLLOWING INFO: PT 1: (B)(6), FEMALE, MDR NUMBER: 3004859032-2016-00001. PT 2: (B)(6), FEMALE, MDR NUMBER: 3004859032-2016-00002. PT 3: (B)(6), FEMALE, MDR NUMBER: 3004859032-2016-00003. MDR 3004859032-2015-00002 WAS RAISED FOLLOWING THE COMPLAINT. THE REPORT HAS BEEN ONGOING AS THE INVESTIGATION REQUIRED FURTHER INFO FROM THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(4) WAS INFORMED ON SEPTEMBER 14, 2015 THAT 2 BATCHES OF BOND ORACLE HER2 IHC SYSTEM - PRODUCT CODE TA9145 (LOTS 27595 AND 20871) WERE USED FOR TESTING PT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86409 BOND ORACLE HER2 IHC SYSTEM NONE MVC LEICA BIOSYSTEMS NEWCASTLE LTD. 20871 AND 27595

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention