BEUDAMED
    FDA Adverse Event Summary report: N

    DAKO

    MDR report key: 5004603 · Received August 14, 2015

    Report

    Report Number
    2022180-2015-00002
    Date Received
    August 14, 2015
    Report Date
    November 3, 2015
    Manufacturer
    DAKO NORTH AMERICA, INC
    Product Code
    NJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP: AFTER FURTHER INVESTIGATION, DAKO HAS DISCOVERED THAT THE PROBLEM COMPLAINT DESCRIBED IN THIS MDR, 2022180-2015-0002, HAD NOTHING TO DO WITH THE WT1 ANTIBODY. THE ISSUE WAS DISCOVERED TO BE RELATED TO THE ENVISION FLEX+ PRODUCT PROBLEM THAT WAS OUTLINED IN MDR 9610099-2015-2015. THIS INVESTIGATION IS CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, DAKO RECEIVED A COMPLAINT REGARDING THE ROUTINE USE OF THE FLEX MONOCLONAL MOUSE ANTI-HUMAN WILMS' TUMOR 1 (WT1) PROTEIN CLONE 6F-H2 ON THE AUTOSTAINER LINK 48 FOR DIAGNOSTIC USE. INITIALLY THE CUSTOMER REPORTED FALSE POSITIVE STAINING, CLAIMING THAT THIS STAINING CONTRIBUTED TO A DIAGNOSTIC ERROR LEADING TO DISTRESS, UNNECESSARY SURGERY AND OTHER INCORRECT TREATMENT. ON AUGUST 12, 2015, DAKO RECEIVED FOLLOW UP INFORMATION REGARDING THIS INCIDENT. THE CUSTOMER REPORTED THAT THEY HAVE REVALIDATED THE SAME BATCH OF WT1 USED IN THE ORIGINAL TESTING AND HAVE CONFIRMED EXPECTED STAINING RESULTS. THE CUSTOMER REPORTED THAT A RETEST WAS ALSO CARRIED OUT AT ANOTHER LABORATORY, ON SECTIONS FROM THE SAME BIOPSY, AND RESULTS WERE ALSO POSITIVE. THE CUSTOMER REPORTED THAT A SEPARATE TEST CAN ON SURGICAL TEST RESECTION TISSUE DONE AT ANOTHER HOSPITAL WAS NEGATIVE. THE CUSTOMER REPORTED THAT AS A RESULT OF THESE CONCLUSIONS, THE CUSTOMER HAS INFORMED DAKO THAT THEY ARE NO LONGER PURSUING A COMPLAINT ABOUT DAKO REGARDING FALSE POSITIVE STAINING WITH THE WT1 ANTIBODY. DAKO IS IN THE PROCESS OF OBTAINING DETAILS OF THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    PLEASE SEE ADDITIONAL MANUFACTURE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540345 DAKO FLEX MONOCLONAL MOUSE (WT1) PROTEIN CLONE 6F-H2, RTU, LINK NJT DAKO NORTH AMERICA, INC IR055 10086975

    Patients

    Seq Age Sex Outcome Treatment
    1 Other