BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOND ORACLE HER2 IHC SYSTEM

    MDR report key: 5153141 · Received October 13, 2015

    Report

    Report Number
    3004859032-2015-00002
    Event Type
    Malfunction
    Date Received
    October 13, 2015
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.
    Product Code
    MVC
    PMA / PMN Number
    P090015
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2016, LEICA BIOSYSTEMS WERE GIVEN THE FOLLOWING INFORMATION. IMAGES OF CELL LINES FROM LOT 27595 HAVE BEEN SENT TO THE (B)(4) FACILITY TO REVIEW. FURTHER CORRESPONDENCE IS TO BE SENT TO THE CUSTOMER TO REQUEST THE IN HOUSE CONTROL SLIDES, PATIENT SAMPLES AND CELL LINES FOR LOTS UNDER COMPLAINT. THIS WILL AID THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT AND CONTROL SLIDES HAVE BEEN RETURNED TO THE MANUFACTURER. THE PATIENT SLIDES DEMONSTRATE POSITIVE STAINING WHICH INDICATES A POSITIVE RESULT FOR HER2. THE PRODUCT HAS PERFORMED AS INTENDED AND INDICATES NO MALFUNCTION. THE CUSTOMER CONFIRMED THE PRODUCT LOT WHICH WAS USED FOR THE 3 PATIENT SLIDES WAS 27595. THE DEVICE HAD BEEN UTILISED.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS WAS INFORMED ON 09/14/2015 THAT 2 BATCHES OF BOND ORACLE HER2 IHC SYSTEM WERE USED FOR TESTING PATIENT SAMPLES. A REVIEW OF THE RESULTS AND FURTHER TESTING BY THE HEALTHCARE PROFESSIONAL DEMONSTRATED 3 PATIENTS SAMPLES MAY HAVE GIVEN A FALSE NEGATIVE RESULT.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS WAS INFORMED ON (B)(6) 2015, THAT 2 BATCHES OF BOND ORACLE HER2 IHC SYSTEM - PRODUCT CODE TA9145 (LOTS 27595 AND 20871) WERE USED FOR TESTING PATIENT SAMPLES. A REVIEW OF THE RESULTS AND FURTHER TESTING BY HEALTHCARE PROFESSIONAL DEMONSTRATED 3 PATIENTS SAMPLES MAY HAVE GIVEN A FALSE NEGATIVE RESULT. LEICA BIOSYSTEMS NEW CASTLE LTD HAVE REQUESTED FURTHER INFORMATION TO AID IN THE INVESTIGATION, TO DATE NO INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS WAS INFORMED ON 14 SEPTEMBER 2015 THAT 2 BATCHES OF BOND¿ ORACLE¿ HER2 IHC SYSTEM - PRODUCT CODE TA9145 (LOTS 27595 AND 20871) WERE USED FOR TESTING PATIENT SAMPLES. A REVIEW OF THE RESULTS AND FURTHER TESTING BY THE HEALTHCARE PROFESSIONAL DEMONSTRATED 3 PATIENTS SAMPLES MAY HAVE GIVEN A FALSE NEGATIVE RESULT.

    Additional Manufacturer Narrative · 2

    ON (B)(4) 2016, LEICA BIOSYSTEMS WERE GIVEN THE FOLLOWING INFORMATION. IMAGES OF CELL LINES FROM LOT 27595 HAVE BEEN SENT TO THE (B)(4) FACILITY TO REVIEW. FURTHER CORRESPONDENCE IS TO BE SENT TO THE CUSTOMER TO REQUEST THE IN HOUSE CONTROL SLIDES, PATIENT SAMPLES AND CELL LINES FOR LOTS UNDER COMPLAINT. THIS WILL AID THE INVESTIGATION.

    Additional Manufacturer Narrative · 3

    ON (B)(4) 2016, LEICA BIOSYSTEMS WERE GIVEN THE FOLLOWING INFORMATION. IMAGES OF CELL LINES FROM LOT 27595 HAVE BEEN SENT TO THE (B)(4) FACILITY TO REVIEW. FURTHER CORRESPONDENCE IS TO BE SENT TO THE CUSTOMER TO REQUEST THE IN-HOUSE CONTROL SLIDES, PATIENT SAMPLES AND CELL LINES FOR LOTS UNDER COMPLAINT. THIS WILL AID THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675316 BOND ORACLE HER2 IHC SYSTEM BOND¿ ORACLE¿ HER2 IHC SYSTEM MVC LEICA BIOSYSTEMS NEWCASTLE LTD. N/A 27595

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other
    2 64 YR
    3 64 YR