BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY

    MDR report key: 8848973 · Received July 31, 2019

    Report

    Report Number
    1649339-2019-00001
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 30, 2019
    Manufacturer
    CELL MARQUE CORPORATION
    Product Code
    NJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CELL MARQUE PURCHASED THE CORRECT MATERIAL, KAPPA (EP171) HOWEVER, THE VENDOR SHIPPED LAMBDA (EP172). REVIEW OF PURCHASE ORDER SHOWED THE CORRECT WAS ORDERED, KAPPA (EP171) FROM THE SUPPLIER BUT THE INCORRECT PRODUCT WAS SENT INSTEAD LAMBDA (EP172). REVIEW OF CUSTOMER COMPLAINTS, 2 OUT OF 3, WERE REPORTING AND INDICATING THAT THEY WERE OBSERVING THE SAME POSITIVE STAINING ON THE KAPPA AS THE LAMBDA ANTIBODY. THE CUSTOMERS QUESTIONED AS TO WHETHER THE MATERIAL IN THE VIALS WERE ACCURATE. FIVE FINISHED PRODUCT LOTS OF KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY WERE FILLED WITH LAMBDA (EP172) RABBIT MONOCLONAL ANTIBODY. THE LOTS AFFECTED WERE: 0000057589,0000057588,0000057618, 0000057617, 0000064775. RELEVAN PART #S: 274R-14 - RUO, 274R-14, 274R-17, 274R-18 THE PRODUCT IS THEREFORE MISBRANDED AND THE LABELING DOES NOT REPRESENT THE CONTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640619 KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY NJT CELL MARQUE CORPORATION 274R 57588, 64775, 57617, 57618

    Patients

    Seq Age Sex Outcome Treatment
    1