BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA BIOSYSTEMS

    MDR report key: 5332286 · Received December 23, 2015

    Report

    Report Number
    3004859032-2015-00005
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    November 27, 2015
    Report Date
    November 27, 2015
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Product Code
    MVU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED UNIT HAS BEEN TESTED AT THE (B)(4) FACILITY USING A KNOWN HPV POSITIVE TISSUE AND APPROPRIATE REAGENT CONTROLS. NO ISSUES WERE OBSERVED WITH THE RESULTING SECTIONS. THE NEGATIVE AND POSITIVE CONTROLS WERE AS EXPECTED. NO FURTHER ACTION REQUIRED. THE CUSTOMER HAS BEEN CONTACTED SEVERAL TIMES TO SEND BACK THEIR UNIT BUT THE CUSTOMER HAS DECIDED NOT TO RETURN THE UNIT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INFORMED LEICA BIOSYSTEMS NEWCASTLE LTD THAT THE TISSUE WAS STAINED AGAIN WITH A DIFFERENT UNIT OF PB0829 FROM A DIFFERENT LOT AND DEMONSTRATED THE CORRECT STAINING. A DIAGNOSIS WAS MADE WITHOUT HAVING TO PERFORM A RE BIOPSY, BUT THERE WAS A DELAY DUE TO RETESTING THE PATIENT TISSUE. THIS PRODUCT IS SOLD AS AN ANALYTE SPECIFIC REAGENT IN THE US.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING A (B)(6) HIGH RISK PROBE (PRODUCT CODE PB0829) NOT STAINING ON A KNOWN POSITIVE CONTROL. THE COMPLAINT STATED 5 DIFFERENT POSITIVE CONTROLS HAD BEEN USED AND DEMONSTRATED NEGATIVE STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849189 LEICA BIOSYSTEMS BOND READ-TO-USE ISH HPV PROBE MVU LEICA BIOSYSTEMS NEWCASTLE LTD 29078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention