BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCEPTEST FOR THE DAKO AUTOSTAINER

    MDR report key: 7598042 · Received June 13, 2018

    Report

    Report Number
    9610099-2018-00002
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 9, 2016
    Report Date
    June 13, 2018
    Manufacturer
    DAKO DENMARK A/S
    Product Code
    MVC
    UDI-DI
    05700572031994
    PMA / PMN Number
    P980018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF DAKO'S INTERNAL AUDIT AND CONTINUOUS IMPROVEMENT PROCESS, DAKO PERFORMED AN INTERNAL REVIEW OF COMPLAINTS BEGINNING WITH THOSE INITIATED JANUARY 1, 2015. THIS REPORT IS BASED ON THAT REVIEW AS COMPLAINT (B)(4) WAS DETERMINED TO BE MDR REPORTABLE. IT IS THEREFORE BEING FILED WITH THE FDA RETROSPECTIVELY. THIS IS AN INITIAL AND FINAL REPORT COMBINED. THE INVESTIGATION FOR THIS CASE WAS CLOSED IN 2016, BUT DURING REVIEW THE CASE HAS BEEN REOPENED AND REASSESSED AS PART OF THE INTERNAL REVIEW.

    Description of Event or Problem · 1

    DEVICE INVOLVED IN THIS COMPLAINT: · K5207, HERCEPTEST FOR DAKO AUTOSTAINER. SUMMARY: INCONSISTENT STAINING ON PRODUCT K5207/HERCEPTEST FOR THE DAKO AUTOSTAINER, LOT NO. 20029667, RESULTED IN A FALSE NEGATIVE. THE CUSTOMER RERAN THE PATIENT TISSUE ON THE HERCEPTEST ASSAY WHICH CONFIRMED THE NEGATIVE TEST RESULT. THE CUSTOMER ALSO RAN A FISH TEST ON THE PATIENT TISSUE WHICH RESULTED IN A POSITIVE RESULT. NO MISDIAGNOSIS OCCURRED AS THE PATIENT WAS DIAGNOSED ACCORDING TO THE FISH TESTING. ASSESSMENT: THE CUSTOMER RAN A FISH ON THE SPECIFIC PATIENT TISSUE AFTER THE IHC TISSUE TEST AND RETEST RESULTED AS NEGATIVE FOR HER2. THE FISH TEST INDICATED THE TISSUE WAS POSITIVE. THE CUSTOMER INDICATED THEY THOUGHT THEIR PROCEDURE WAS THE CAUSE OF NEGATIVE TESTS. A SERVICE ENGINEER WAS SENT ON SITE TO WORK WITH THE CUSTOMER. THE SERVICE ENGINEER CONFIRMED THEIR PROCEDURE. NO ROOT CAUSE OR LIKELY ROOT CAUSE WAS IDENTIFIED. THE SERIAL NUMBER OF THE AUTOSTAINER WAS NOT RECORDED IN THE COMPLAINT. AS PART OF ITS INTERNAL REVIEW, DAKO ANALYZED WHETHER THERE WERE ANY ADDITIONAL COMPLAINTS LOGGED ON THE CUSTOMER'S LOT NUMBER AND NO OTHER COMPLAINTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437308 HERCEPTEST FOR THE DAKO AUTOSTAINER HERCEPTEST FOR THE DAKO AUTOSTAINER MVC DAKO DENMARK A/S 20029667 05700572031994

    Patients

    Seq Age Sex Outcome Treatment
    1 Other