BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA BIOSYSTEMS

    MDR report key: 5273523 · Received December 4, 2015

    Report

    Report Number
    3004859032-2015-00004
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Date of Event
    October 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Product Code
    NJT
    Removal / Correction Number
    1423337-16-11-2015-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INITIALLY REVIEWED AND DETERMINED TO BE NON REPORTABLE AS THERE WAS NO OBVIOUS MALFUNCTION. IT WAS BELIEVED IT DID NOT WORK CORRECTLY DUE TO THE CUSTOMER USING A DIFFERENT PROTOCOL THAN WHAT IS STATED IN THE INFO FOR USE BOOKLET. THE RETAINED UNIT WAS ALSO TESTED AND FOUND TO WORK OPTIMALLY. THE CUSTOMER KIT WAS RETURNED AND TESTED, WHICH THEN LED TO THE UNDERSTANDING THE PRODUCT DID MALFUNCTION. AN INVESTIGATION WAS PERFORMED AND A RECALL OF THE AFFECTED PRODUCTS IS NOW UNDERWAY. THE ROOT CAUSE OF THE MALFUNCTION IS A MANUAL FILL OF THE PRODUCT HAS BEEN CONDUCTED WITH THE INCORRECT COMPONENT.

    Additional Manufacturer Narrative · 1

    A PRODUCT RECALL WAS INITIATED ON 11/16/2015, OF (B)(4) BATCHES OF (B)(4) BOND POLYMER REFINE RED DETECTION WHICH HAVE THE POTENTIAL TO BE AFFECTED BY THE SAME FAILURE MODE AS THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, LEICA (B)(4) RECEIVED A COMPLAINT REGARDING DS9390 BOND POLYMER REFINE RED DETECTION BATCH 41919 TO STATE THERE WAS NO STAINING OBSERVED WHEN USING THIS PRODUCT. THE CUSTOMER WAS NOTED TO USE THE PRODUCT FOLLOWING A DIFFERENT PROTOCOL TO WHAT IS SPECIFIED IN THE INFO FOR USE BOOKLET. THE PRODUCT WAS RETURNED FOR ANALYSIS AND FOUND TO NOT PERFORM CORRECTLY WHEN TESTED USING THE CORRECT PROTOCOL. THE TESTING WAS CONCLUDED ON (B)(6) 2015. THIS IS THE DATE THE ROOT CAUSE WAS IDENTIFIED AS A MALFUNCTION WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797020 LEICA BIOSYSTEMS BOND POLYMER REFINE RED DETECTION NJT LEICA BIOSYSTEMS NEWCASTLE LTD 41619

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK